Aripiprazole in Children and Adolescents With Bipolar Disorder and Attention Deficit Hyperactivity Disorder (ADHD)

Study Overview
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Brief Summary
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There is a scarcity of clinical trials assessing the effects of medications in children with bipolar disorder. This study aims to assess the efficacy of Aripiprazole (a novel anti-psychotic drug) for the treatment of children and adolescents with bipolar disorder comorbid with ADHD. The study design is a 8-week randomized, double blind, parallel group trial. Patients were randomized to either aripiprazole or placebo. The main hypotheses are: Aripiprazole will significantly reduce maniac scores compared to placebo Aripiprazole will significantly reduce ADHD scores compared to placebo

Detailed Description
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Bipolar disorder (BD) is a chronic disorder that severely affects the normal development of children and adolescents. The disorder is associated with high rates of suicide tentative and high-risk behaviors like sexual promiscuity and drug abuse. Bipolar disorder in children is also associated with high rates of comorbidity, especially with Attention-Deficit Hyperactivity Disorder (ADHD). There is a scarcity of clinical trials assessing the effects of medications in children with BD. Moreover, the frequent presence of comorbid ADHD might determine lower response to treatment. Aripiprazole is a novel anti-psychotic drug. Its mechanism of action seems to be related to a stabilization of dopaminergic transmission, acting as a partial agonist especially in dopaminergic D2 receptors. It also has effects in 5-HT1a serotonergic receptors. Thus, it might have a promising effect in children and adolescents with comorbid BD and ADHD. A retrospective chart review, recently published, suggests the efficacy of this drug in children with BD. This study aims to assess the efficacy of Aripiprazole (a novel anti-psychotic drug) for the treatment of 50 children and adolescents (age range: 08 to 17 years-old) with Bipolar Disorder comorbid with ADHD. The study design is an 6-week randomized, double blind, parallel group trial. Patients were randomized to either aripiprazole or placebo. The hypotheses are: 1) Aripiprazole will significantly reduce maniac scores compared to placebo; 2)Aripiprazole will significantly reduce ADHD scores compared to placebo; 3) Aripiprazole will not be significantly associated to weight gain compared to placebo.

Official Title
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Aripiprazole in Children and Adolescents With Bipolar Disorder and ADHD: A Randomized Double Blind Placebo Controlled Trial

Conditions
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Bipolar Disorder, Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: Aripiprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 8-17 BD type I or II comorbid with ADHD Baseline score in the YMRS > or = 20 Exclusion Criteria: IQ < 70 Pharmacologic treatment in the last month Pregnancy or absence of a contraceptive method in fertile girls Diagnoses: pervasive development disorder, schizophrenia, drug abuse or dependency Risk of suicide or homicide Clinical condition that might interfere in the study Known sensibility to aripiprazole

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aripiprazole|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores in the Young Mania Rating Scale (BD) |  |  | 
| Scores in the SNAP-IV (ADHD) |  |  | 
| Weight |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores in the CMRS-P |  |  | 
| Scores in CGI |  |  | 
| Scores in the CDRS |  |  | 
| Scores in the Kutcher Adolescent Depression Scale |  |  | 
| Scores of quality of life (YQOL-R) |  |  | 
| Report of side events |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical trial, aripiprazole, Bipolar Disorder, Attention-Deficit Hyperactivity Disorder, ADHD