Overview

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

Status:
Completed
Trial end date:
2008-02-01
Target enrollment:
0
Participant gender:
All
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
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Federal University of Rio Grande do Sul
Collaborator:
Hospital de Clinicas de Porto Alegre
Treatments:
Aripiprazole
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