Aripiprazole Associated With Methylphenidate in Children and Adolescents With Bipolar Disorder and ADHD
Condition: Bipolar Disorder; Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Bipolar Disorder; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      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 associated with
      Methylphenidate (MPH)for the treatment of children and adolescents with bipolar disorder
      comorbid with ADHD who improve in maniac symptoms while receiving aripiprazole but did not
      have an adequate response in ADHD symptoms. The study design is a 4-week randomized, double
      blind, cross-over group trial. Patients were randomized to aripiprazole + MPH or aripiprazole
      + placebo. The main hypothesis is: Aripiprazole + MPH will significantly reduce ADHD scores
      compared to aripiprazole + placebo.
    

Detailed description: 
      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 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 associated
      with Methylphenidate (MPH) for the treatment of 20 children and adolescents (age range: 8 to
      17 years-old) with Bipolar Disorder comorbid with ADHD who improve in maniac symptoms while
      receiving aripiprazole but did not have an adequate response in ADHD symptoms. The study
      design is a 4-week randomized, double blind, cross-over group trial. Patients were randomized
      to aripiprazole + MPH or aripiprazole + placebo. The hypotheses are: 1) Aripiprazole + MPH
      will significantly reduce ADHD scores compared to aripiprazole + placebo. 2) Patients
      receiving aripiprazole + MPH will not deteriorate in maniac symptoms.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: clinical trial; aripiprazole; methylphenidate; Bipolar Disorder; Attention-Deficit Hyperactivity Disorder; ADHD