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Clinical Trial Summary

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.


Clinical Trial Description

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00181987
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Completed
Phase Phase 4
Start date August 2002
Completion date August 2005

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