Status:
COMPLETED
Concerta in the Treatment of ADHD in Youth and Adults With Bipolar Disorder
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
ADHD
Bipolar Disorder
Eligibility:
All Genders
6-55 years
Phase:
PHASE4
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, Bipola...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00181987
Start Date
August 1 2002
End Date
August 1 2005
Last Update
October 22 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138