Concerta in the Treatment of ADHD in Youth and Adults With Bipolar Disorder
|ClinicalTrials.gov Identifier: NCT00181987|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : October 22, 2013
|Condition or disease||Intervention/treatment||Phase|
|ADHD Bipolar Disorder||Drug: methylphenidate HCl (Concerta)||Phase 4|
A leading source of difficulty in treating youth with Bipolar Disorder is its comorbidity with attention deficit hyperactivity disorder (ADHD). Systematic studies of children and adolescents show that rates of ADHD range from 60% to 90% in pediatric study participants with mania. These findings could not be accounted for by the overlapping symptoms of distractibility, talkativeness, and physical hyperactivity, suggesting that affected children may suffer from both disorders, which was also consistent with findings of familial co-transmission of these two conditions. Considering the well-documented morbidity and dysfunction associated with ADHD, a comprehensive treatment approach to the management of the bipolar child with comorbid ADHD requires the development of appropriate therapeutic strategies for the treatment ADHD symptoms.
The objective of this study is to investigate the safety and effectiveness of Concerta in the treatment of children (ages 5 to 17 years old) and adults (ages 18 to 55 years old) with Bipolar I, Bipolar II and Bipolar Spectrum Disorder and comorbid ADHD over 8 weeks. This study seeks to study the short-term effectiveness of a long acting formulation of methylphenidate (Concerta) in the treatment of children and adults with bipolar disorder and comorbid ADHD adequately stabilized on an acceptable and stable regimen of anti-mania agents.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label Study of Concerta in the Treatment of ADHD in Youth and Adults With Bipolar I, Bipolar II, and Bipolar Spectrum Disorder|
|Study Start Date :||August 2002|
|Actual Primary Completion Date :||August 2005|
|Actual Study Completion Date :||August 2005|
- Scores on the Young Mania Rating Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181987
|United States, Massachusetts|
|Massachusetts General Hospital|
|Cambridge, Massachusetts, United States, 02138|
|Principal Investigator:||Joseph Biederman, MD||Massachusetts General Hospital|