Clinical trial NCT00116259: Aripiprazole in Children and Adolescents With Bipolar Disorder and Attention Deficit Hyperactivity Disorder (ADHD)
Official title: Aripiprazole in Children and Adolescents With Bipolar Disorder and ADHD: A Randomized Double Blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Attention Deficit Hyperactivity Disorder
Keywords: clinical trial
aripiprazole
Bipolar Disorder
Attention-Deficit Hyperactivity Disorder
ADHD
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Hospital de Clinicas de Porto Alegre
First posted: 2005-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 (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:

1. Aripiprazole will significantly reduce maniac scores compared to placebo
2. Aripiprazole will significantly reduce ADHD scores compared to 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Scores in the Young Mania Rating Scale (BD)
measure: Scores in the SNAP-IV (ADHD)
measure: Weight
Secondary outcomes:
measure: Scores in the CMRS-P
measure: Scores in CGI
measure: Scores in the CDRS
measure: Scores in the Kutcher Adolescent Depression Scale
measure: Scores of quality of life (YQOL-R)
measure: Report of side events
Other outcomes:
Locations:
city: Porto Alegre - Brazil
country: Brazil
facility: ADHD outpatient program
state: RS
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Luis A Rohde, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.