Metabolic Effects of Antipsychotics in Children (MEAC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00205699|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Aggression ADHD Oppositional Defiant Disorder PDD Bipolar Disorder||Drug: risperidone Drug: olanzapine Drug: aripiprazole||Phase 4|
The proposed randomized clinical trial aims to assess both the safety and efficacy of atypical antipsychotic agents in antipsychotic-naive aggressive children with various childhood psychiatric disorders during 12 weeks of prospective, randomized treatment with olanzapine (Zyprexa), risperidone (Risperdal) or aripiprazole (Abilify).
Aim 1: To evaluate effects of selected antipsychotic treatments on insulin action in skeletal muscle (glucose disposal), liver (glucose production) and adipose tissue (lipolysis).
Aim 2: To evaluate effects of selected antipsychotic treatments on insulin secretion.
Aim 3: To evaluate effects of selected antipsychotic treatments on abdominal fat mass, total body fat and total fat-free mass.
Aim 4: To evaluate effects of selected antipsychotic treatments on resting metabolic rates (carbohydrate and fat oxidation).
Aim 5: To evaluate effects of selected antipsychotic treatments on efficacy for symptoms of aggression.
Important secondary aims include the assessment of non-metabolic adverse events, and the assessment of each antipsychotic treatment condition in children with and without concomitant stimulant therapy. Reduced adverse metabolic effects are hypothesized during concomitant stimulant therapy. Children aged 7-18 will be studied, exploring age-related differences in vulnerability to treatment-induced adverse metabolic changes. Finally, treatment effects on regulatory hormones, including cortisol, glucagon, leptin, ghrelin and adiponectin will be explored. This will allow the assessment of possible confounds to the interpretation of the primary hypotheses. It will also permit the generation of additional hypotheses concerning mechanisms contributing to drug-induced changes in weight and fat mass. Relevant data on the primary and secondary aims are critically needed to assess the risks as well as benefits of clinical therapy in children, to identify needs for additional basic research, as well as to guide administrative and regulatory decision-making.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metabolic Effects of Antipsychotics in Children|
|Study Start Date :||October 2004|
|Primary Completion Date :||June 2011|
|Study Completion Date :||July 2011|
|Active Comparator: randomized treatment||
randomized to begin 12 week trial of ziprasidone
Other Name: RisperdalDrug: olanzapine
randomized to begin 12 week trial of olanzapine
Other Name: ZyprexaDrug: aripiprazole
randomized to 12 week trial of aripiprazole
Other Name: Abilify
- To evaluate effects of selected antipsychotic treatments on insulin action in skeletal muscle (glucose disposal), liver (glucose production) and adipose tissue (lipolysis). [ Time Frame: 12 weeks and 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00205699
|United States, Missouri|
|Washington University School of Medicine, Psychiatry Dept.|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||John W. Newcomer, M.D.||Washington University School of Medicine and Florida Atlantic University|
|Principal Investigator:||Ginger Nicol, MD||Washington University School of Medicine|