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Concerta in the Treatment of ADHD in Youth and Adults With Bipolar Disorder

Primary Purpose

ADHD, Bipolar Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
methylphenidate HCl (Concerta)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring ADHD, bipolar disorder, children, Concerta

Eligibility Criteria

6 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female subjects, 5-55 years of age. Each subject, as well as the legal representative for children under the age of 18, must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol. Each subject (and his/her authorized legal representative, if applicable) must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the study participant must sign an informed assent document. Subjects must have a diagnosis of Bipolar I, Bipolar II, Bipolar NOS or sub-threshold Bipolar Disorder with a stable Young Mania Scale rating of < 15 for at least one month, a Depression CGI-Severity score < 3 (mildly ill), a score on the Hamilton Depression Rating Scale below 15 (mild range), and a comorbid diagnosis of ADHD according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kiddie Schedule of Affective Disorders or Structured Clinical Interview DSM-IV), subjects may not have expressed symptoms for past 20 years. Subject must be able to participate in mandatory blood draws. Subject must be able to swallow pills. Exclusion Criteria: Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild. Serious, unstable illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease Uncorrected hypothyroidism or hyperthyroidism. History of severe allergies or multiple adverse drug reactions. Non-febrile seizures without a clear and resolved etiology. Leukopenia or history of leukopenia without a clear and resolved etiology. Judged clinically to be at serious suicidal risk. Any other concomitant medication with primarily central nervous system activity other than specified in Concomitant Medication portion of the protocol History of intolerance or non-responder to Concerta as determined by the principal investigator. 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.

Sites / Locations

  • Massachusetts General Hospital

Outcomes

Primary Outcome Measures

Scores on the Young Mania Rating Scale
CGI-ADHD
ADHD-RS

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
October 21, 2013
Sponsor
Massachusetts General Hospital
Collaborators
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00181987
Brief Title
Concerta in the Treatment of ADHD in Youth and Adults With Bipolar Disorder
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 Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Bipolar Disorder
Keywords
ADHD, bipolar disorder, children, Concerta

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
methylphenidate HCl (Concerta)
Primary Outcome Measure Information:
Title
Scores on the Young Mania Rating Scale
Title
CGI-ADHD
Title
ADHD-RS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects, 5-55 years of age. Each subject, as well as the legal representative for children under the age of 18, must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol. Each subject (and his/her authorized legal representative, if applicable) must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the study participant must sign an informed assent document. Subjects must have a diagnosis of Bipolar I, Bipolar II, Bipolar NOS or sub-threshold Bipolar Disorder with a stable Young Mania Scale rating of < 15 for at least one month, a Depression CGI-Severity score < 3 (mildly ill), a score on the Hamilton Depression Rating Scale below 15 (mild range), and a comorbid diagnosis of ADHD according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kiddie Schedule of Affective Disorders or Structured Clinical Interview DSM-IV), subjects may not have expressed symptoms for past 20 years. Subject must be able to participate in mandatory blood draws. Subject must be able to swallow pills. Exclusion Criteria: Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild. Serious, unstable illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease Uncorrected hypothyroidism or hyperthyroidism. History of severe allergies or multiple adverse drug reactions. Non-febrile seizures without a clear and resolved etiology. Leukopenia or history of leukopenia without a clear and resolved etiology. Judged clinically to be at serious suicidal risk. Any other concomitant medication with primarily central nervous system activity other than specified in Concomitant Medication portion of the protocol History of intolerance or non-responder to Concerta as determined by the principal investigator. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Biederman, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States

12. IPD Sharing Statement

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Concerta in the Treatment of ADHD in Youth and Adults With Bipolar Disorder

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