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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116259
• Other study ID #: GPPG03-325a
• Secondary ID: GPPG03-325a
• Status: Completed
• Phase: N/A
• First received: June 27, 2005
• Last updated: August 6, 2008
• Start date: March 2005
• Est. completion date: February 2008

Study information

• Verified date: August 2008
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Bipolar Disorder
• Disease
• Hyperkinesis

Intervention

Drug:
• Aripiprazole

Locations

Country	Name	City	State
Brazil	ADHD outpatient program	Porto Alegre - Brazil	RS

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul	Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores in the Young Mania Rating Scale (BD)
Primary	Scores in the SNAP-IV (ADHD)
Primary	Weight
Secondary	Scores in the CMRS-P
Secondary	Scores in CGI
Secondary	Scores in the CDRS
Secondary	Scores in the Kutcher Adolescent Depression Scale
Secondary	Scores of quality of life (YQOL-R)
Secondary	Report of side events