Clinical Trials
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Psychiatry/Mental Health
Cognitive Remediation in ADHD Children : Comparison Between Three Therapeutic Strategies : Cognitive Remediation With a Virtual Classroom Software and Methylphenidate and Supportive Psychotherapy (RECOGNITA)
Mar 2013The Attention Deficit Disorder with or without Hyperactivity (ADHD) is one of the most frequently found disorder in children. It is characterized by a triad of symptoms involving attention deficit, hyperactivity and impulsivity and having an impact on the functioning of the subject especially in terms of learning. Currently, main interventions to treat ADHD in children are stimulant medication or supportive psychotherapy. Data from recent studies highlight the use of stimulant drugs (amphetamine derivatives such as methylphenidate) to treat the core symptoms of ADHD children. These drugs are generally effective but their nature (psychostimulants) and adverse effects they cause (appetite suppression, sleep disturbances, headaches, motor tics, abdominal pain, irritability, nausea and fatigue) encourage the development of new therapeutic approaches. The use of supportive psychotherapy alone would have limited effect on symptoms of children with ADHD. Our aim is to test the use a cognitive remediation program using a virtual classroom in children suffering from ADHD.
Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support
Mar 2013The purpose of this study is to investigate whether face-to-face Cognitive Behavioral Therapy (CBT) with a smartphone application, focused on providing support in homework assignments and an increase in behavioral activation, is effective in treating mild to moderate depression. The study will be conducted as a randomized controlled treatment study investigating the effect of the current blended treatment compared to treatment as usual.
Agomelatine Treatment of Depression in Schizophrenia (AGOPSYCH)
Mar 2013Major depressive episodes (MDEs) occur frequently during the course of psychotic disorders, and several antidepressive agents have been successfully applied. The new melatonergic antidepressant agomelatine (AGO) appears promising for the treatment of MDEs in schizophrenia for several reasons. The investigators plan to test the efficacy and tolerability of AGO for antidepressive treatment in schizophrenia. For this task, the investigators plan to enrol 27 schizophrenic patients into an open, single-armed, prospective clinical trial with agomelatine.
The Effect of Minocycline on Relapse After Successful Intravenous Ketamine/Minocycline-induced Symptoms Response in Subjects With Depression
Mar 2013The purpose of this study is to assess whether the antidepressant effect from intravenous (IV) ketamine treatment can be maintained by minocycline compared to placebo after IV ketamine treatment is stopped.
Internetbased Relapse Prevention for Partially Remitted Depression (ISAK)
Mar 2013The main purpose of the study is to test whether Internet-based relapse prevention plus medication has a better protective effect compared to medication only, for persons with residual depressive symptoms who are currently in paid employment or in education.
Essential Fatty Acids in Adult ADHD (OCEAN-GER)
Feb 2013The aim of this project is to investigate the effect of a dietary supplementation with essential fatty acids in adults on cognitive functions related to attention and impulse control in the general population and in individuals with a diagnosis of attention deficit hyperactivity disorder (ADHD).
Efficacy of Omega-3/Omega-6 Fatty Acids in Pre-school Children at Risk for ADHD
Feb 2013The efficacy of PUFAs (as nutritional supplement) in/for pre-school children with ADHS symptoms will be evaluated in a randomised controlled doubleblind trail with children aged 3-6 years.
A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders
Feb 2013This multi-center, randomized, double-blind, parallel group, placebo-controlled, proof of concept study will investigate the efficacy and safety of RG7314 in adult patients with autism spectrum disorders. In stage I of the study, patients will be randomized to receive daily oral doses of 1.5 mg RG7314or placebo for 12 weeks. After an independent safety review, the study may proceed to stage II. In stage II of the study, additional patients will be randomized to receive daily oral doses of 1.5mg, 4 mg of RG7314 or placebo for 12 weeks. After an interim efficacy and safety analysis, additional patients may be randomized to receive daily oral doses of 1.5 mg, 4 mg of RG7314 or placebo for 12 weeks. The anticipated time on study treatment is 12 weeks.
The Effects of DHA on Attention Deficit and Hyperactivity Disorder (DADA)
Feb 2013The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in reducing Attention Deficit/Hyperactivity Disorder (ADHD) core symptoms in a clinical sample of children and adolescents with ADHD.
iCBT for Depression - Standard Versus Condensed Treatment Material (KONRAD)
Feb 2013In this study the investigators will assess reading speed and the ability to concentrate in all patients and then randomise them to an internet-based treatment for depression using either a standard material or a condensed one. The condensed material consists of 30000 words and will be available as text files and on audio files. The standard material consists of 60000 words and is only available as text files. Both groups will have the possibility of e-mail contact with a personal therapist during the treatment.
Interventional, open-label, flexible-dose extension study of brexpiprazole in patients with schizophrenia
Jan 2013The primary objective is to evaluate long-term safety and tolerability of brexpiprazole
A 26-week, Multicenter, Open-label, Extension Study of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in Patients with Schizophrenia
Jan 2013The primary objective of this open-label trial is to evaluate the safety and tolerability of aripiprazole intramuscular (IM) depot administered for 26 weeks to subjects with schizophrenia.
Melatonin Dose-effect Relation in Childhood Autism (MELADOSE)
Jan 2013Melatonin is a neurohormone produced from serotonin which promotes sleep. The alterations in central and peripheral serotonin neurobiology and in circadian sleep-wake rhythms observed in autistic disorder suggest abnormalities in melatonin secretion. Several studies have reported a decrease in melatonin secretion in individuals with autism. Furthermore, nocturnal excretion of 6-Sulphatoxymelatonin (the predominant melatonin metabolite) was significantly negatively correlated with severity of autistic impairments in verbal communication and play. Melatonin could therefore have a therapeutic effect on sleep problems and may play a role in the pathophysiology of autistic disorder. These data highlight the possible therapeutic interest of an oral administration of melatonin in patients with autistic disorder. Thus, the objective of this clinical trial is to study the relation between the melatonin dose administered and its effect on severity of autistic impairments especially in verbal communication and play.
Cytochrome P450-2D6 Screening Among Elderly Using Antidepressants (CYSCE)
Jan 2013Depression is common among elderly with an estimated prevalence of 5%. Due to ageing the national burden will double in the coming decade. Antidepressants as TCAs and SSRIs are effective in reducing symptoms, especially in people with severe depression. To optimize treatment efficacy and reduce side effects, the Pharmacogenetics Working Group of the Royal Dutch Pharmacists Association developed guidelines for dose-adaptation, for instance for antidepressants such as nortriptyline and venlafaxine based on their main relevant genotype (CYP2D6) accompanied by Therapeutic Drug Monitoring. Such personalized drug dosing based on pharmacogenetic information at the start of therapy can speed up the titration phase of antidepressants to establish an adequate maintenance dose. However, pharmacogenetic screening programs are expensive and evidence on effects and costs of such a program among elderly antidepressant starters from randomized controlled studies is lacking. The investigators will conduct a pragmatic randomized controlled trial to determine the effects and costs of pharmacogenetic screening information to optimize drug dosing in depressed elderly patients who start with nortriptyline or venlafaxine. Objective: The primary objective is to determine the effects of pharmacogenetic screening for CYP2D6 on the time to reach adequate blood levels as an accepted proxy for adequate treatment. Secondary objectives include adverse drug reactions and cost-effectiveness
Cerebral Reorganization in Schizophrenia
Jan 2013The purpose of this study is to reveal the specific effects of computer-aided cognitive training on cerebral reorganization in schizophrenia
Neuroplasticity-oriented Cognitive Intervention in Early Onset and First Admission Schizophrenia
Jan 2013The purpose of this study is to reveal the specific effects of computer-aided cognitive training on course and rehabilitation in early onset schizophrenia
Deep Brain Stimulation of the Superolateral Branch of the Medial Forebrain Bundle (slMFB) for the Treatment of Refractory Major Depression (FORESEEII)
Jan 2013The investigators will investigate in a sham controlled staggered onset design antidepressant effects and safety of deep brain stimulation (DBS) to the superolateral branch of the main medial forebrain bundle (slMFB).
Omega-3 Fatty Acids Supplementation in ADHD
Jan 2013The overarching aim of the proposed study is to assess whether omega-3 fatty acids supplementation can augment the effects of methylphenidate in children with ADHD. The investigators hypothesized that omega-3 fatty acids supplementation will be associated with improved ADHD symptoms.
Neurophysiological Molecular and Developmental Analysis of the Glutamate Synapse in Autism (NMDA-Autism)
Jan 2013Neurophysiological, Molecular and Developmental Analysis of the glutamate synapse in Autism
Pharmacokinetics and safety of agomelatine in children (from 7 to less than 12 years) and adolescents (from 12 to less than 18 years) with Major Depressive Disorder. An open-labelled, multicenter, three-dose level, non-comparative study.
Jan 2013The primary objective is to evaluate pharmacokinetics of 3 doses of agomelatine in patients from 7 to less than 18 years suffering from Major Depressive Disorder.
Prevention of depression and poor physical function in older persons with vitamin D supplementation
Jan 2013The primary objective of the D-Vitaal trial is to answer the following two questions: 1. Does vitamin D supplementation decrease depressive symptoms in older persons? 2. Does vitamin D supplementation improve physical performance and decrease functional limitations in older persons?
Trial of Telephone-based Psychotherapy for Depression With and Without Adjunctive Supportive Mail (Tel-PT)
Jan 2013This study aims to compare the effectiveness of two telephone-based psychotherapy (Tel-PT) interventions for patients with mild to moderate depression. Both interventions consist of one personal session and weekly to bi-weekly 8-10 telephone sessions with a licensed cognitive-behavioral psychotherapist accompanied by the study of educational materials and the completion of regular monitoring questionnaires (total treatment duration: approximately 3 months). Patients are randomized into one of two conditions: Patients in the condition "Tel-PT including mail" additionally receive a motivating letter from their psychotherapist after each telephone session, while patients in the condition "Tel-PT without mail" receive no further interventions. Patients refusing to be randomized are to be assigned to the condition "Tel-PT without mail". This study takes place within a larger study evaluating a stepped care model for depression (01KQ1002B-TP7).
Treatment of antipsychotic associated obesity with a GLP-1 Analogue: the TAO study
Jan 2013To investigate if 3 months treatment with a GLP-1-analogue can reduce antipsychotic associated obesity in non-diabetic patients with a diagnosis within the schizophrenic spectrum
The Relationship of Essential Fatty Acids to Adult ADHD: The OCEAN Study (Oils and Cognitive Effects in Adult ADHD Neurodevelopment)
Dec 2012The aim of the study is to provide preliminary data on the relationship of Essential Fatty Acids (EFAs) to cognitive and electrophysiological measures of brain and behavioural functions in adults with attention deficit hyperactivity disorder (ADHD) and controls. This main aim will be achieved in two ways. First the investigators will measure the relationship of the various measures to blood levels of EFAs in ADHD cases and controls. Secondly, the potential effects of dietary supplementation with EFAs on cognitive-electrophysiological and behavioural measures in ADHD cases will be investigated. We will evaluate the extent to which changes in neuronal activity and cognitive performance are related to behavioural and functional measures over time. This is to be carried out by conducting a randomised controlled trial of fish oil supplementation in adults with ADHD (The OCEAN study: Oils and Cognitive Effects in Adult Neurodevelopment).
The Efficacy of EMDR in Patients With PTSD in Multiple Sclerosis
Nov 2012The primary aim is to evaluate the efficacy of the treatment with Eyes Movement Desensitization and Reprocessing(EMDR) in PTSD secondary to MS. EMDR is the elective treatment (together with Cognitive Behavioural Therapy) for PTSD according to international guidelines. The secondary aims are to evaluate the efficacy of EMDR on the PTSD-associated symptoms of anxiety and depression and Quality of Life. The study design is a randomized clinical trial.
A 12-week, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia
Nov 2012To evaluate the overall efficacy of aripiprazole IM depot as acute treatment in subjects with schizophrenia.
Relapse prevention in children and adolescents with DSM-IV-TR conduct disorder treated with risperidone: a randomised, double-blind, placebo-controlled discontinuation study.
Nov 2012The primary objective is to test the hypothesis that, after at least 16 weeks of daily administration (4 for titration, 12 of relatively stable dose, 4 of which at fixed doses; Study Period 1), risperidone given orally at a dose of 0.25-3.0 mg/day depending on body weight (equivalent to approximately 0.01-0.04 mg/kg/day is superior to placebo in preventing relapse of the symptoms of conduct disorder as assessed through a 12 week double-blind discontinuation trial (Study Period 2) of children and adolescents with conduct disorder and no developmental delay/mental retardation. This will be measured by comparing the mean change from the double-blind baseline to endpoint in the Nisonger Child Behaviour Rating Form Typical IQ version-ODD/CD disruptive behaviour composite total score (Aman et al., 2008) using all investigator ratings, based on all available information.
A Study to Assess Learning Performance in Patients With Schizophrenia and Young and Elderly Healthy Volunteers
Nov 2012The purpose of this study is to measure and contrast implicit and explicit learning performance in patients with schizophrenia relative to young and elderly healthy volunteers.
Improving Work Outcome for People With Severe Mental Illness
Nov 2012The purpose of this study is to investigate the efficacy of IPS in Denmark and compare effects of 1. Individual Placement and Support (IPS) vs. 2. IPS + cognitive remediation and work-related social skills training vs. 3. standard intervention, among individuals with severe mental illness.
A pilot study of Concerta XL in adult offenders with ADHD
Oct 2012The main question is to evaluate the effectiveness of a standard treatment for ADHD on behavioural problems, that are associated with ADHD in young male prisoners. The primary question is whether there is a decrease in aggressive behaviour following treatment of ADHD in a prison setting. Aggression is one of the main problem behaviours within the prison and previous research has shown the strong link between ADHD and aggression within adult prison populations.
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Once a Day, TAK-375 (Ramelteon) Tablet for Sublingual Administration (TAK-375SL Tablet) 0.1 mg and 0.4 mg as an Adjunctive Therapy in the Treatment of Acute Depressive Episodes Associated With Bipolar 1 Disorder in Adult Subjects
Oct 2012To evaluate the efficacy of TAK-375SL tablet 0.1 mg and 0.4 mg once daily at bedtime (QHS) compared with placebo as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS) after 6 weeks of treatment in subjects with acute depressive episodes associated with Bipolar 1 Disorder.
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Safety and Efficacy Study of Oral ELND005 as an Adjunctive Maintenance Treatment in Patients with Bipolar I Disorder
Oct 2012To assess the efficacy of ELND005 compared to placebo as adjunctive maintenance therapy in patients with BPD I. To assess the safety and tolerability of ELND005 in BPD I patients.
Phase shift in adult ADHD of sleep and apetite.
Sep 2012To investigate the best treatment of the Delayed Sleep Phase Syndrome in adults with ADHD.
Apathy in Schizophrenia
Sep 2012Apathy, defined as a quantitative reduction of voluntary, goal-directed behaviours (GDB), is a core component of negative symptoms. It has been suggested that the physiopathology of apathy is not a single entity but may be multiple, depending on which specific process or macrofunction is disrupted during completion of GDB. In line with this notion, Levy and Dubois proposed dividing apathic syndromes into three subtypes of disrupted processing: 'a-motivation', 'cognitive inertia', and 'uncoupling'. In schizophrenia, apathy has been associated with executive dysfunction, functional impairment and poor outcome. However, the neurobiological underpinnings of apathy in schizophrenia are poorly understood. Primary objective: confirm that chronic schizophrenic patients are apathic compared to healthy volunteers
An open label study with objective sleepregistration on the effects of Doxazosin as treatment for PTSD, especially for sleep disturbance
Aug 2012The purpose of this study is to evaluate the effect on sleep and ptsd of the drug doxazosin in patients with PTSD who also have sleep problems.
The SPD489-322 Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of SPD489 in Combination with an Antidepressant in the Treatment of Adults with Major Depressive Disorder with Inadequate Response to Prospective Treatment with an Antidepressant
Aug 2012The primary objective is to demonstrate the efficacy of SPD489 when used as augmentation therapy in the treatment of major depressive disorder (MDD) in inadequate responders following an 8-week course of treatment with an antidepressant, as measured by the mean change in Montgomery-?sberg Depression Rating Scale (MADRS) total scores.
Guided Self-Help for Parents of Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Aug 2012Cognitive-behavioral based guided self-help for parents of adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) is investigated in a feasibility and effectiveness study. The treatment is offered under routine-care conditions of the health-care system in Germany. Practicability, treatment participation and effectiveness is documented and tested in a one-group pre-test/post-test design.
Oxytocin in PTSD: effectiveness as addition to Narrative Exposure Therapy
Jul 2012The primary objective is to assess the effectiveness of the administration of intranasal oxytocin in addition to Narrative Exposure therapy (NET) in reducing PTSD and co-morbid depressive symptoms in patients with chronic PTSD, compared to administration of placebo. We hypothesize that both groups will show a reduction in PTSD and depressive symptoms over the course of the treatment, but that the reduction in symptoms will be faster and larger in the oxytocin group.
A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel-group Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS)
Jul 2012Evaluate the efficacy and safety of ABT-126 in the treatment of cognitive deficits in schizophrenia (CDS).
An Non-Interventional Study of Patients With Persistent Symptoms of Schizophrenia
Jul 2012This multicenter, prospective, non-interventional study will evaluate the prevalence and characteristics of patients with persistent symptoms of schizophrenia and the course of their illness over 24 months.
Propofol vs. Ketamin
Jun 2012Better therapeutic effect of ketamin in the treatment of ECT
A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of the Safety and Efficacy of Memantine in Pediatric Patients with Autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated with Memantine
Jun 2012To evaluate the safety, tolerability, and efficacy of memantine therapy compared with placebo in pediatric patients with autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) previously on stable memantine therapy utilizing a randomized withdrawal paradigm.
An Open-Label Study Of The Safety And Tolerability Of Memantine In Pediatric Patients With Autism, Asperger’s Disorder, Or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Jun 2012The objective of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in the follow-up randomized withdrawal study
Enhancement of Methylphenidate Treatment by Psychosocial Intervention and Support
Jun 2012The main purpose of this study is to evaluate the effectiveness of a parenting enhancement training (PET) for parents with children diagnosed with Attention Deficit-/Hyperactivity Disorder (ADHD) who are already medicated with methylphenidate.
Insight in Persons Presenting Schizophrenia or Related Troubles During Hospitalization in Psychiatry
May 2012Therapeutic alliance, and drug observance are major difficulties in the care of persons presenting schizophrenic symptomatology. They appear to be linked to insight, the consciousness that one has of his troubles. Nurse care in psychiatry aims at improving it, but usually without using specific evaluation tool. Insight is usually not evaluated during care, and its evolution is also not known, although it is highly probable that a positive evolution of insight for a person in hospital correlated to an adapted and optimal care by the medical and nursing teams. The investigators do not know examples of insight evaluation during a sequence of hospital care, or any evidence of insight variation in relation to evolution abilities of some schizophrenic patients cared in hospital. The investigators propose here to evaluate insight in people presenting schizophrenia or related troubles, at the beginning of hospitalization (I1) and 1 month later (I2), to better characterize insight variations, and identify the sociodemographic, clinical and therapeutic variables linked to it.
A Multicenter, Open-Label, Flexible-Dose Extension Study of Lurasidone Adjunctive to Lithium or Divalproex in Subjects with Bipolar I Disorder
May 2012The primary objective of the study is to evaluate the longer term safety and tolerability of lurasidone flexibly dosed at 20, 40, 60 or 80 mg/day over a 12-week period in subjects with bipolar I disorder who have previously been treated with lurasidone.
Ketamine augmentation of ECT to improve outcomes in depression
May 2012Ketamine vs saline treatment will reduce ECT-induced cognitive impairments as measured by being able to learn new verbal information (anterograde verbal memory), remember personal events from their past (autobiographical memory) and saying the names of objects fluently (verbal fluency)
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Flexible Dose Study on the Efficacy of Lu AA21004 on Cognitive Dysfunction in Adult Subjects with Major Depressive Disorder (MDD)
Apr 2012To evaluate the efficacy of treatment with flexible doses of Lu AA21004 (10 or 20 mg QD) versus placebo on cognitive dysfunction in patients with MDD.
Interventional randomised, double-blind, parallel-group, placebo-controlled, exploratory study investigating the effects of Lu AA21004 on cognition and BOLD fMRI signals in subjects remitted from depression and controls
Apr 2012• to determine whether Lu AA21004 compared to placebo in subjects remitted from depression modulates the blood oxygen level dependent (BOLD) signal in functional magnetic resonance imaging (fMRI) of the brain areas associated with executive function (working memory) during performance of the N-back task. The regions of interest are within the prefrontal cortex and anterior cingulate • to determine whether Lu AA21004 compared to placebo in subjects remitted from depression modulates the blood oxygen level dependent (BOLD) signal in functional magnetic resonance imaging (fMRI) of the brain areas associated with spatial memory during performance of the Arena task., The region of interest is hippocampus • to evaluate the effects of Lu AA21004 compared to placebo in subjects remitted from depression on the BOLD signal in fMRI in other brain regions involved in the regulation of cognitive processes during working memory and planning performance (N-back and Arena task)
A double-blind, placebo-controlled, multicenter, parallel group study to assess efficacy, safety and tolerability of TC-5619 as augmentation therapy to improve negative symptoms and cognition in outpatients with schizophrenia
Apr 2012To assess the efficacy of TC-5619 to improve negative symptoms and cognition when used as augmentation therapy to atypical antipsychotics in stable outpatients with schizophrenia
A Multicenter, Double-Blind, Placebo-Controlled Study of JNJ-40411813 as Adjunctive Treatment to an Antidepressant in Adults with Major Depressive Disorder with Anxiety Symptoms
Apr 2012To evaluate the efficacy, as assessed by the change from baseline on a 6-item subscale derived from the Hamilton Anxiety Scale (HAM-A6), and overall safety and tolerability of treatment with adjunctive JNJ-40411813 compared to placebo in patients with MDD with anxiety symptoms being treated with an antidepressant.
The effect of treatment of traumatised refugees with Traume-Focused Cognitive Behavioural Therapy and antidepressants - a randomised controlled clinical trial.
Mar 2012To evaluate the treatment effect of pharmacotherapy with Mianserine and Sertraline and trauma-focused cognitive behavioural therapy in traumatised refugees
The treatment of traumatized refugees with Setraline versus Venlafaxine - a randomized trial.
Mar 2012To investigate whether or not there is a difference in the treament effect of Venlafaxine and Sertraline on PTSD symptoms in traumatized refugees.
A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects with Schizophrenia
Mar 2012To demonstrate, in patients stabilized on the paliperidone palmitate 1 month formulation (PP1M), that paliperidone palmitate 3 month formulation (PP3M) is not less effective than PP1M in the treatment of symptoms of schizophrenia, based on the Kaplan-Meier 48-week cumulative estimate of survival (ie, percentage of subjects remaining relapse free).
Boosting oxytocin after trauma: The effects of intranasal oxytocin administration on emotional and motivational brain processes in PTSD
Mar 2012In this functional Magnetic Resonance Imaging (fMRI) study, the primary objective is to examine the acute effects of intranasal OT administration on emotional- and reward-related brain processes in PTSD patients compared to traumatized healthy controls. Furthermore, we aim to examine gender differences in the effects of intranasal OT administration on functional (task-specific) brain activation and in structural anatomy (i.e. volume and white matter integrity) between PTSD patients and traumatized healthy controls.
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms (Study 299)
Mar 2012To evaluate the treatment effect of AMG 747 compared to placebo on negative symptoms as measured by the Negative Symptom Assessment Scale (NSA-16) in patients with schizophrenia stabilized with ongoing antipsychotic therapy
The treatment of traumatized refugees with Setraline versus Venlafaxine - a randomized trial.
Mar 2012To investigate whether or not there is a difference in the treament effect of Venlafaxine and Sertraline on PTSD symptoms in traumatized refugees.
A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects with Schizophrenia
Mar 2012To demonstrate, in patients stabilized on the paliperidone palmitate 1 month formulation (PP1M), that paliperidone palmitate 3 month formulation (PP3M) is not less effective than PP1M in the treatment of symptoms of schizophrenia, based on the Kaplan-Meier 48-week cumulative estimate of survival (ie, percentage of subjects remaining relapse free).
The Effects of Long-acting Methylphenidate on Academic Activity and Related Constructs in Children with ADHD: A Randomised Placebo Controlled Trial
Mar 2012The primary objective of this study is to explore the relationship between MPH and academic activity and the mediating roles of ADHD behaviours, cognitive deficits and motivational deficits in this relationship. Therefore, the direct effects of MPH on ADHD behaviours, cognitive deficits and motivational deficits are taken into account. In particular, evidence on the effects of MPH on motivational deficits in ADHD is scarce. It is hypothesized that treatment with MPH results in increased academic activity as compared to placebo control. If MPH improves academic activity, comparisons with the control group will be made to see if academic activity in children with ADHD normalises when treated with MPH.
Ketamine in treatment resistant major depression (TRD)
Mar 2012Effectiveness of a single i.v. application of the NMDA antagonist ketamine at subanaesthetic doses will be tested The study will extend prior reports of open label studies in exploratory sample sizes to a double blinded placebo controlled study on a larger sample of 40 patients.
Effects of agomelatine versus escitalopram on emotional experiences in outpatients suffering from Major Depressive Disorder. An exploratory, randomised, double-blind, international, multicentre study with parallel groups: agomelatine (25 to 50 mg/day) versus escitalopram (10 to 20 mg/day) over a 6- month period.
Mar 2012The purpose of this exploratory study is to differentiate the effect of two antidepressants, agomelatine versus escitalopram, on the emotional experiences in outpatients suffering from Major Depressive Disorder.
A Double-Blind, Double-Randomization, Placebo-Controlled Study of the Efficacy of Intravenous Esketamine in Adult Subjects with Treatment-Resistant Depression
Mar 2012The primary objective of the study is to evaluate the efficacy, safety, and tolerability of esketamine in subjects with treatment resistant depression. Efficacy in improving symptoms compared with a placebo will be assessed by the changes from randomisation to end of week 1 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms (Study 165)
Mar 2012To evaluate the treatment effect of AMG 747 compared to placebo on negative symptoms as measured by the Negative Symptom Assessment Scale (NSA-16) in patients with schizophrenia stabilized with ongoing antipsychotic therapy
Effects of agomelatine (25 to 50 mg/day) on circadian rhythms in patients with Major Depressive Disorder. An exploratory 6-week open, flexible dose, international multicentre, non comparative study.
Feb 2012Assess the effect of agomelatine on the circadian rhythms in Major Depressive Disorder patients by evaluating circadian parameters.
A Phase IIa, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-6096 for Treatment Augmentation in Patients with Major Depressive Disorder.
Jan 2012(1) To evaluate the efficacy of MK-6096 in comparison with placebo as treatment augmentation for patients with MDD, based on change from baseline to week 6 in MADRS total score. (2) To assess the safety and tolerability of MK-6096 as augmentation therapy for patients with MDD.
Adults With Attention Deficit Hyperactivity Disorder (ADHD): Validation of a Clinical Interview and Screening Instruments in French
Jan 2012ADHD is a neurodevelopmental disorder that affects about 5% of school-age children and 3.5% of adults worldwide. This condition is under-recognised in France and other European countries and, therefore, under-diagnosed. As part of the European Network for Adult ADHD, the investigators translated into French a structure interview called the Diagnostic Interview for Adult ADHD (DIVA). The investigators also translated rating scales such as the ASRS and the WURS. Validation studies are rare in France. The aim of this study is to include two groups of 50 adults whether they have or not ADHD with respect of Diagnostic and Statistical Manual - Revision 4(DSM-IV) criteria as implemented in the DIVA (i.e. actual at adulthood and past in childhood). Subjects have to fill out a booklet of questionnaires including the WHO's Adult ADHD Symptom Rating Scale (ASRS) (screening tool for actual diagnosis) and the Wender Utah Rating Scale (WURS, a screening tool for ADHD in childhood with respect of the Utah criteria). The investigator will be able to compare the actual criteria for ADHD between the ASRS and the DIVA, and the past criteria for ADHD between the WURS and the DIVA. Finally, an estimate of the prevalence of ADHD in adults will be computed.
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of RO4995819 Versus Placebo, as Adjunctive Therapy in Patients with Major Depressive Disorder Having Inadequate Response to Ongoing Antidepressant Treatment
Jan 2012To evaluate the efficacy of 6 weeks treatment of RO4995819 versus placebo as adjunctive therapy in patients with MDD having inadequate response to ongoing antidepressant treatment based on mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores from baseline to end of treatment.
Adipose Derived Stem Cell Therapy for Autism
Dec 2011The intent of this clinical study is to answer the questions: - Is the proposed treatment safe - Is treatment effective in improving the disease pathology of patients with Autism.
A Double-blind, Placebo-controlled Study of Cariprazine (RGH-188) as Adjunctive Therapy In Major Depressive Disorder.
Dec 2011The objectives of this study are to evaluate the efficacy, safety, and tolerability of cariprazine adjunctive to ADT in patients with major depressive disorder who have an inadequate response to ADT.
Efficacy of RAD001/everolimus in Autism and NeuroPsychological deficits in children with TSC (RAPIT-trial)
Dec 2011The primary objective is to determine the effect of Everolimus on the cognition of children with TSC, measured by IQ.
Efficacy of agomelatine on sleep disturbance in Autism Spectrum Disorder (ASD)
Nov 2011To study the efficacy of agomelatine in improving the quantity and quality of sleep in patients with ASD as recorded by an integrated variable TAP.
A Phase 3, Open-label, Multicentre, Protocol to Provide Access to Guanfacine Hydrochloride Extended Release for European Subjects with Attention-deficit/Hyperactivity Disorder (ADHD) who Participated in Study SPD503-315 or SPD503-316
Nov 2011The primary objective of this study is to evaluate the long term saftey of SPD503.
International Study to Predict Optimized Treatment - in Attention-Deficit and Hyperactivity Disorder
Nov 2011The primary objectives of the iSPOT-A trial are to use Brain Resource's standardized 'Integrative Neuroscience' test batteries to 1) Identify objective markers of ADHD compared with healthy controls, using cognitive, brain and genetic markers
A multicenter, Double-blind 58 week Rollover Study to assess the Safety and Tolerability of BMS-820836 in Patients with Treatment Resistant Major Depression.
Oct 2011The purpose of this study is to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.
Investigating Cognitive Behavioral Therapy in Patients With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders
Sep 2011The purpose of this study is to determine if cognitive behavioral therapy is effective in treating ADHD symptoms in patients with substance use disorders and comorbid ADHD.
Boosting the oxytocin system in acute trauma: The effectiveness of intranasal oxytocin treatments and stimulation of social support on preventing trauma related psychopathology
Sep 2011In recently traumatized individuals (at the latest on day ten post trauma exposure) with a high initial level of distress, we aim to assess the effectiveness of intranasal OT and a semi-structured social support intervention in preventing symptoms of PTSD at one and three months post trauma follow-up.
A randomized, double-blind, placebocontrolled, flexible-dose, parallel-group, Study of Lurasidone adjunctive to Lithium or Divalproex for the prevention of recurrence in subjects with bipolar I disorder
Aug 2011To evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and/or psychotic features.
A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Maintenance Treatment in Adults with Schizophrenia
Aug 2011To assess the long-term safety and tolerability of oral OPC-34712 as monotherapy in adults with schizophrenia. This trial is to be conducted on an outpatient basis.
Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication according to the the ABCB1 Gene
Aug 2011To evaluate the ABCB1-genotype dependent efficacy of a quick dose-escalation strategy within 21 days of treatment with approved antidepressants that are known substrates of the P-glycoprotein, an efflux pump of the blood-brain barrier expressed by ABCB1
A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study
Aug 2011To evaluate the long-term safety, tolerability and effectiveness of lurasidone in eligible subjects who have completed a prior lurasidone extension study.
A Preliminary Study of Intravenous Ketamine in Selective Serotonin Reuptake Inhibitor (SSRI)-Resistant Depression
Aug 2011To evaluate if IV ketamine treatment given weekly over 3 weeks relieves depressive symptoms in patients who have not responded to SSRI (Selective Serotoninn Reuptake Inhibitors) Antidepressants.
A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Jun 2011The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder. Efficacy will be assessed by the mean change from baseline in the total score from the 30-Item Inventory of Depressive Symptomatology–Clinician-Rated (IDS-C30).
Social Cognitive Development in Young Children With Autism
Jun 2011Through the development of a novel treatment targeting core Autism Spectrum Disorder (ASD) social deficits and studying the efficacy of this intervention, the investigators hope to provide a means for children with ASD to more effectively and efficiently process social information and enable them to more successfully engage in social interactions. Children between the ages of 24 and 36 months and their families may join.
A 6-month, open-label extension to a 40-week, randomized, double-blind, placebo-controlled, multicenter efficacy and safety study of Ritalin® LA in the treatment of adult patients with childhood-onset ADHD
May 2011To evaluate the long-term safety of Ritalin LA administered once daily for six months during open-label treatment in adults with ADHD.
Toolkit for School Behavior Modification in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Apr 2011The purpose of this study is to examine the efficacy of the ADHD-Toolkit (a toolkit for school behaviour modification in primary school children with ADHD-behaviours) in terms of general improvement in ADHD symptoms, specific targeted school-related problem behaviours, other disruptive behaviour disorder symptoms, teacher attitudes towards ADHD, teacher-child relationship and child self-esteem.
LY2216684 compared to Placebo as Adjunctive Therapy to SSRI in the Prevention of Symptom Re-emergence in Major Depressive Disorder
Mar 2011The aim of the study is to assess the time to re-emergence of depressive symptoms
Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder
Mar 2011The goal of this work is to identify genes associated with good response of bipolar patients to two commonly used mood stabilizing agents, lithium and valproate. 1. All patients will be started on lithium, then enter the maintenance phase where they will be followed for 2 years or until relapse. Those that fail lithium will be crossed over to valproic acid (VPA). Those that fail on VPA will be again crossed-over to a standardized treatment as usual (TAU) arm.
Pregabalin for anxiety comorbidity in patients with schizophrenia (PACS) - A Double-blinded Randomized Placebo Controlled Trial
Jan 2011To investigate the effect and tolerability of pregabalin for schizophrenic patients that suffer from comorbid anxiety.
Optimization of Treatment and Management of Schizophrenia in Europe
Dec 2010(I) To test applicability of amisulpride as the first step in a treatment algorithm. (II) To test guideline recommendation that non-responders to an antipsychotic drug benefit from a switch to an antipsychotic with a different receptor binding profile. (III) To provide the acceptability and outcome data on the application of clozapine in non-responding patients within the first 10 weeks of their treatment initiation.
Behavioral effects and neural correlates of oxytocin on social attention
Dec 2010The overall aim of the proposed project is to investigate attentional processes in a social context and to modulate these processes by OXT. Based on the literature to date, it seems plausible that OXT modulates social cognitive processes such as the attention to emotional facial expressions differentially in ASD and neurotypical controls. Thus, the present study aims to investigate the modulatory role of OXT on attentional capture of social stimuli with varying emotional valence on the behavioral level in both typically developing adults as well as individuals with ASD. Participants will receive either OXT or a placebo in a randomized, double-blind group design.
A randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of Ritalin® LA in adult patients with childhood-onset ADHD
Nov 2010Main objectives of the trial are; To confirm the clinically effective dose range of Ritalin LA in adults with childhood onset ADHD as measured by the change from Baseline to the end of a 9-week, fixed-dose treatment period in DSM-IV Attention-Deficit/Hyperactive Disorder Rating Scale (DSM-IV ADHD RS) total score. To evaluate improvement in functional impairment will be measured by the change from baseline in total score on the Sheehan Disability (SDS) is a self-rating scale designed to assess the functional impairment of patients with ADHD at the end of a 9-week fixed-dose treatment period. To evaluate the maintenance of effect of Ritalin LA in adults with childhood onset ADHD as measured by the percentage of Ritalin LA vs. placebo treatment failures at the end of a 6-month treatment withdrawal period. To evaluate the safety of Ritalin LA in adults with childhood onset ADHD as measured by the frequency of AEs, the results of laboratory tests, and the measurement of vital signs and ECGs.
Effects of methylphenidate on the development of the dopaminergic system in the brain
Nov 2010To report on the age-dependency of the effect(s) of MPH treatment on the outgrowth of the DA system using state-of-the-art Magnetic Resonance Imaging (MRI) techniques
A Phase 4, Open-label, Multicentre, 2-Year Safety Study of Lisdexamfetamine Dimesylate in Children and Adolescents Aged 6-17 Years with Attention-Deficit/Hyperactivity Disorder (ADHD)
Oct 2010To evaluate the long-term safety of SPD489 administered as a daily morning dose (30, 50, and 70mg) in the treatment of children and adolescents (6-17 years of age inclusive at the time of consent in this study or a previous SPD489 study (SPD489-317, SPD489-325, or SPD489-326) diagnosed with moderately to severely symptomatic ADHD.
A Phase 3, Randomised, Double-blind, Multicentre, Parallel-group, Placebo- and Active-reference, Dose-optimisation Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents aged 6-17 years with Attention-Deficit/Hyperactivity Disorder
Oct 2010The primary efficacy analysis will be performed on the change from baseline for the ADHD-RS-IV total score at Visit 15 using Last-Observation-Carried Forward (LOCF) methodology, for all subjects randomised and receiving study drug. The mean change from baseline will be compared between treatments using an Analysis of Covariance (ANCOVA) model. The primary treatment comparison is SPD503 versus placebo. The ANCOVA model will include treatment group (the effect of interest), the corresponding baseline score (the covariate), and the blocking factors age group (6-12 years or 13-17 years) and country. The null hypothesis states that there is no difference between SPD503 and placebo, with the 2-sided alternative of a non-zero difference between groups.
A Phase 3, Double-blind, Placebo-controlled, Multicentre, Randomised withdrawal, Long-term Maintenance of Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 With Attention deficit/Hyperactivity Disorder
Aug 2010The primary efficacy outcome for each subject is treatment failure during the double-blind randomised-withdrawal phase (Phase 2). The primary efficacy analysis will compare treatment failure rates between treatments (SPD503 and placebo) for all subjects who enter Phase 2 using a Cochran-Mantel-Haenszel (CMH) test stratified by age group and country. Subjects who discontinue for any reason during the randomised-withdrawal phase will be classed as treatment failures for the primary analysis. The null hypothesis states that there is no difference in treatment failure rate between SPD503 and placebo, with the 2-sided alternative of a non-zero difference between groups.
Attention Deficit Hyperactivity Disorder (ADHD) and opioid maintenance therapy. A randomized, placebo-controlled study of the efficacy of atomoxetine for treating adult ADHD in patients receiving opioid maintenance therapy
Jul 2010To estimate the efficacy of atomoxetine when treating ADHD in patients with comorbid opioid dependence.
OCTUMI-4: Evaluation of Mirtazapine and Folic Acid for Schizophrenia: A randomised, double-blind, 2x2 factorial trial
Jul 2010Principal research question: Is mirtazapine as add-on therapy to antipsychotic treatment more effective than placebo for treatment of positive and negative symptoms of schizophrenia? Current treatments for schizophrenia, primarily antipsychotic drugs, are not fully effective. There is some evidence that treatment with mirtazapine plus an antipsychotic may be more effective than an antipsychotic alone ((Berk, Ichim & Brook 2001; Joffe et al. 2009; Zoccali et al. 2004)). OCTUMI-4 is designed to evaluate the effects of mirtazapine as add-on therapy to antipsychotic treatment in patients with schizophrenia who are currently experiencing active psychotic symptoms. OCTUMI-4 will be a double-blind placebo controlled randomised trial.
Genetic Contributions to Autism Spectrum Disorders
Jul 2010This study is working towards gaining a better understanding of the genetic and environmental factors involved in autism spectrum disorders (ASD), which includes autism, pervasive developmental disorder (PDD), and Asperger's syndrome. The investigators hope that information gained from this study will lead to new ways of diagnosing and treating ASDs.
Randomized controlled trial of escitalopram versus placebo for patients with irritable bowel syndrome and panic disorder.
Jun 2010To assess the efficacy of Escitalopram vs placebo in the treatment of IBS patients with panic disorder
A 6-Month, Open-Label, Flexible-Dosage (150 to 200 mg/day) Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Jun 2010The primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder whose most recent episode was a depressive episode.
Evaluation of an Intervention for Improving Community-based Pediatric Attention-Deficit Hyperactivity Disorder (ADHD) Care
Jun 2010Evaluation of an Intervention for Improving Community-based Pediatric ADHD Care
A Single Centre, Open-Label, Randomised Multi-Dose Study to Assess Changes in the Brain Metabolism of Juvenile ADHD Patients After Thirteen Weeks of Daily Intake of 4 g Superba Krill Oil or 4 g omega-3 Enriched Fish Oil
May 2010To evaluate changes in the brain metabolism of juvenile ADHD patients after thirteen weeks of daily doses of 4 g Superba krill oil or 4 g omega-3 enriched fish oil
ADHD - Voice Analysis, Vocal Acoustic Biomarkers in Attention Deficit Hyperactivity Disorder
Apr 2010The purpose of this study is to detect specific vocal acoustic patterns in the voice of attention deficit hyperactivity disorder (ADHD) patients.
Short- and long-term effects of oxytocin on empathy and social behaviour in autistic and antisocial male adults.
Apr 2010To investigate the effectiveness of 4-weeks treatment with intranasally adminsitered oxytocin twice a day versus placebo in improving social behaviour in patients with antisocial personality disorder and in those with autism spectrum disorder
The effectiveness of Parent-Child Interaction Therapy versus methylphenidate in preschool children with ADHD and disruptive behavior problems with insufficient improvement through Parent Management Training.
Mar 2010The primary aim of our study will be to investigate the effectiveness of PCIT in comparison with methylphenidate in children with ADHD and disruptive behavior problems aged 2;6 till 6 years who have not responded sufficiently to previously offered PMT.
A Phase 3b, Double-blind, Randomised, Active-controlled, Parallel-group Study to Compare the Time to Response of Lisdexamfetamine Dimesylate to Atomoxetine Hydrochloride in Children and Adolescents aged 6-17 years with Attention Deficit/Hyperactivity Disorder (ADHD) Who Have Had an Inadequate Response to Methylphenidate Therapy.
Jul 2009The primary objective of this study is to compare the time to response of lisdexamfetamine dimesylate (SPD489) with that of atomoxetine hydrochloride (STRATTERA) in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate (MPH) treatment where inadequate response includes, but is not limited to, the presence of some residual symptoms, inadequate duration of action and/or variability of symptom control, and/or Investigator feels that the subject may derive benefit from an alternative treatment to MPH therapy. The primary efficacy measure is time to response; where individual subject response is assessed using the Clinical Global Impressions – Global Improvement (CGI-I) Scale.
Why methylphenidate is not successful in cocaine-dependent ADHD patients: a SPECT study comparing DAT before and after methylphenidate treatment in ADHD patients with and without cocaine dependence
May 2009To determine why methylphenidate is not successful in cocaine-dependent ADHD patients, using SPECT to comparing DAT before and after methylphenidate treatment in ADHD patients with and without cocaine dependence
Neurocognitive testing in children with ADHD
Jun 2008Main objectives of the trial are; 1. to measure the effects of methylphenidate using the Neurocart test battery, to establish if these effects can be differentiated from placebo and to determine circadian variation in effect, 2. to describe the drug concentrations of methylphenidate in saliva, 3. to describe the PK/PD relationship using the obtained saliva samples, 4. to describe cardiovascular effects of methylphenidate (blood pressure and heart rate); 5. to evaluate clinical treatment effect during the trial, 6. to evaluate how children have experienced trial participation.
A Phase III, Open-Label, Extension, Multicentre, Safety Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 with Attention-Deficit/Hyperactivity Disorder (ADHD)
May 2008The primary objective of this study is to evaluate the long-term safety of LDX administered as a daily morning dose (30, 50, and 70mg/day) in the treatment of children and adolescents (6 -17 years of age inclusive at the time of consent for the antecedent study, SPD489-325) diagnosed with moderately symptomatic ADHD. The evaluation of safety will be based on the occurrence of treatment-emergent adverse events (TEAEs), specific evaluation of blood pressure and pulse, electrocardiogram (ECG) results, clinical laboratory test results, and physical examination findings.
Influence of methylphenidate on sleep and circadian rhythm in children with Attention-Deficit/Hyperactivity Disorder (ADHD)
Nov 2007Determine the influence of methylphenidate treatment on sleep-wake rhythm and endogenous melatonin rhythm in children with ADHD.
Prazosin as add-on therapy in the pharmacological treatment of sleep disturbances in post traumatic stress disorder, a placebo-controlled study using polysomnography
Aug 2007Efficacy of prazosin in PTSD related sleep disturbances, as measured with polysomnography and self administered sleep questoinnaires
A Randomized, Controlled, Open-Label Study of the Long-Term Impact on Functioning using Atomoxetine Hydrochloride Compared to Other Early Standard Care in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Treatment-Naïve Children and Adolescents. (ADHD-LIFE Study)
Feb 2007The primary objective is to test the hypothesis that atomoxetine given at individually titrated doses for 6 months is superior to other early standard therapy in improving quality of life as measured by the mean change in the achievement domain of the Child Health and Illness Profile – Child Edition, Parent Report Form (CHIP-CE PRF), in pharmacologically naïve children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).
Omega-3 Fatty Acids Supplementation for Adolescent Boys with Attention Deficit Hyperactivity Disorder : a double-blind, randomized controlled trial
Apr 2006ADHD symptoms are often carried through to the adolescent period and long-term intervention is often needed. Patients and their parents often choose alternative treatments for ADHD. Omega-3 fatty acids supplementation is one popular alternative treatment, and relatively safe, but the effectiveness has not been assessed enough . This study aims to evaluate whether EFA supplementation improves ADHD symptoms in ADHD male adolescents.
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