Status:
COMPLETED
Aripiprazole Associated With Methylphenidate in Children and Adolescents With Bipolar Disorder and ADHD
Lead Sponsor:
Federal University of Rio Grande do Sul
Conditions:
Bipolar Disorder
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
8-17 years
Phase:
PHASE4
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 associated with Methylphenidate (M...
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 and high-risk behaviors like...
Eligibility Criteria
Inclusion
- Age: 8 -17
- BD type I or II comorbid with ADHD
- Reduction of maniac symptoms (30% reduction in the YMRS scores and/or CGI scores ≤ 2)while using aripiprazole during a previous study (NCT00116259)without improvement of ADHD symptoms (reduction in ADHD symptoms \< 30% in the SNAP-IV). Those receiving placebo in the previous protocol will receive a 6- week open label treatment with aripiprazole. The same threshold for reducing maniac symptoms and absence of response in ADHD symptoms will be used.
Exclusion
- IQ \< 70
- 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 :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00305370
Start Date
August 1 2005
End Date
March 1 2008
Last Update
August 7 2008
Active Locations (1)
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1
ADHD Outpatient Program
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003