NCT00116259|Completed
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Sponsor study identifier
Secondary identifiers
interventional
50
1 country
1
Study Start
March 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2008
Actual (reported)Study Completion
February 2008
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2008
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2005
Date type not reportedThis date has not been verified as actual or estimated.
June 27, 2005
Actual (reported)June 28, 2005
Actual (reported)January 2008
Actual (reported)February 2008
Actual (reported)Scores in the Young Mania Rating Scale (BD)
Scores in the SNAP-IV (ADHD)
Weight
Scores in the CMRS-P
Scores in CGI
Scores in the CDRS
Scores in the Kutcher Adolescent Depression Scale
Scores of quality of life (YQOL-R)
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ADHD outpatient program
Porto Alegre - Brazil, Rio Grande do Sul, 90035-003, Brazil
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. doi: 10.1017/s1092852900019489.
Tramontina S, Zeni CP, Ketzer CR, Pheula GF, Narvaez J, Rohde LA. Aripiprazole in children and adolescents with bipolar disorder comorbid with attention-deficit/hyperactivity disorder: a pilot randomized clinical trial. J Clin Psychiatry. 2009 Apr 21;70(5):756-64. doi: 10.4088/JCP.08m04726.
Luis A Rohde, MD
Federal University of Rio Grande do Sul
First Submitted
June 27, 2005
First Posted
June 28, 2005
Study Start
March 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2008
Actual (reported)An Open-Label Trial of Aripiprazole in Children and Adolescents With Bipolar Disorder
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Study Completion
February 2008
Actual (reported)Last Updated
August 7, 2008
Record last verified: 2008-08
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Source: ClinicalTrials.gov.
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