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

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

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

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

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.

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

Biederman J, McDonnell MA, Wozniak J, Spencer T, Aleardi M, Falzone R, Mick E. Aripiprazole in the treatment of pediatric bipolar disorder: a systematic chart review. CNS Spectr. 2005 Feb;10(2):141-8. doi: 10.1017/s1092852900019489.

Tramontina S, Zeni CP, Ketzer CR, Pheula GF, Narvaez J, Rohde LA. Aripiprazole in children and adolescents with bipolar disorder comorbid with attention-deficit/hyperactivity disorder: a pilot randomized clinical trial. J Clin Psychiatry. 2009 Apr 21;70(5):756-64. doi: 10.4088/JCP.08m04726.