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| Sponsor: | Massachusetts General Hospital |
|---|---|
| Collaborator: |
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00181987 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
ADHD Bipolar Disorder |
Drug: methylphenidate HCl (Concerta) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 29 |
| Study Start Date: | August 2002 |
| Study Completion Date: | August 2005 |
| Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 6 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Treatment with nonreversible monoamine oxidase inhibitor within 2 weeks prior to initiation of study.
Current diagnosis of schizophrenia. 12. Diagnosis of any chronic motor or vocal tic, or Tourette's Syndrome.
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Cambridge, Massachusetts, United States, 02138 | |
| Principal Investigator: | Joseph Biederman, MD | Massachusetts General Hospital |
More Information
| Responsible Party: | Massachusetts General Hospital ( Joseph Biederman, MD ) |
| Study ID Numbers: | 2002-P-001148 |
| Study First Received: | September 13, 2005 |
| Last Updated: | July 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00181987 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
ADHD bipolar disorder children Concerta |
|
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Disease Molecular Mechanisms of Pharmacological Action Bipolar Disorder Physiological Effects of Drugs Methylphenidate Central Nervous System Stimulants |
Pharmacologic Actions Affective Disorders, Psychotic Pathologic Processes Mental Disorders Therapeutic Uses Mood Disorders Dopamine Agents Central Nervous System Agents |