Overview
Aripiprazole in Children and Adolescents With Bipolar Disorder and Attention Deficit Hyperactivity Disorder (ADHD)
Status:
Completed
Completed
Trial end date:
2008-02-01
2008-02-01
Target enrollment:
0
0
Participant gender:
All
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 placeboPhase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Federal University of Rio Grande do SulCollaborator:
Hospital de Clinicas de Porto AlegreTreatments:
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