Status:
COMPLETED
Aripiprazole in Children and Adolescents With Bipolar Disorder and Attention Deficit Hyperactivity Disorder (ADHD)
Lead Sponsor:
Federal University of Rio Grande do Sul
Collaborating Sponsors:
Hospital de Clinicas de Porto Alegre
Conditions:
Bipolar Disorder
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
8-17 years
Phase:
NA
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 ...
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 beha...
Eligibility Criteria
Inclusion
- Age: 8-17
- BD type I or II comorbid with ADHD
- Baseline score in the YMRS \> or = 20
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00116259
Start Date
March 1 2005
End Date
February 1 2008
Last Update
August 7 2008
Active Locations (1)
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1
ADHD outpatient program
Porto Alegre - Brazil, Rio Grande do Sul, Brazil, 90035-003