Status:
COMPLETED
Reducing Medical Risks in Individuals With Bipolar Disorder - Full Study
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Bipolar I Disorder
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The primary aim of this project is to understand whether it is possible to reduce medical risk factors in adults with bipolar disorder and, in doing so, to improve psychiatric and functional outcomes....
Detailed Description
IRRI is aimed at improving sleep/wake and social rhythm disturbance and achieving modest weight reduction by increasing physical activity and improving nutrition and dietary habits, while at the same ...
Eligibility Criteria
Inclusion
- Age 18 to 55 years
- Body mass index (BMI) \>25
- Meets DSM-IV criteria for lifetime bipolar I disorder
- Is in remission (with possible sub-threshold symptoms), i.e., as a HRDS-25 \< or equal to 10, YMRS \< or equal to 8, and CGI-BP-S \<3 for two weeks
- Able to give basic informed consent
- Current diagnosis or past history of anxiety disorder, eating disorder, or other psychiatric comorbidities will not be exclusion criteria for participation, except those listed in the exclusion criteria below
Exclusion
- Ultra-rapid cycling (\>8 episodes per year) bipolar I disorder
- Presence of pervasive developmental disorder, antisocial personality disorder, current substance dependence or abuse, and organic mental disorder
- Unstable and severe medical illness that requires immediate and intensive medical attention, for instance, a subject with a terminal illness or a subject with severe and unstabilized coronary artery disease; these subjects will be immediately referred to the most appropriate medical and psychiatric treatment. When appropriate, the subjects can be reconsidered for inclusion in the study if/when their medical condition becomes compatible with participation in a protocol-driven research study
- Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations)
- Not competent to provide informed consent in the opinion of the investigator
- Women who are planning to become pregnant, currently pregnant, or breast-feeding
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00746343
Start Date
September 1 2008
End Date
September 1 2013
Last Update
December 12 2013
Active Locations (1)
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1
Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213