Reducing Medical Risks in Individuals With Bipolar Disorder - Full Study (MedRisk)
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ClinicalTrials.gov Identifier: NCT00746343 |
Recruitment Status
:
Completed
First Posted
: September 4, 2008
Last Update Posted
: December 12, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bipolar I Disorder | Behavioral: IRRI Behavioral: PCCM | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 122 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Reducing Medical Risks in Individuals With Bipolar Disorder - Full Study |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | September 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: IRRI
The integrated risk reduction intervention (IRRI) consists of three components:
|
Behavioral: IRRI
Subjects will remain in their assigned treatment condition for 24 months. IRRI subjects will meet with the lifestyle coach 25-27 times throughout the duration of the study.
Other Name: Integrated Risk Reduction Intervention
|
Experimental: PCCM
Psychiatric Care with Medical Monitoring (PCMM) The psychiatric care with medical monitoring condition (PCMM) consists of two components:
The treating psychiatrist will be assisted by a psychiatric nurse clinician who will assess and monitor the subject's medical needs and refer the subject to their primary care physician for care. |
Behavioral: PCCM
Subjects will remain in their assigned treatment condition for 24 months.
Other Name: Psychiatric care with medical monitoring condition
|
- Integrated risk reduction intervention (IRRI), compared with psychiatric care with medical monitoring, will result in a larger decrease in medical risk factors and a greater improvement in sleep/wake and social rhythm disturbances. [ Time Frame: Entry and every 6 months of participation for two years ]
- Integrated risk reduction intervention compared with psychiatric care with medical monitoring will result in greater improvement in mood symptoms and functioning, particularly employment-related functioning. [ Time Frame: Entry and every 6 months of participation for two years ]
- The effect of integrated risk reduction intervention on improved mood symptoms and functioning will be mediated by the effect of integrated risk reduction intervention on medical risk factors and on sleep/wake and social rhythm disturbances. [ Time Frame: 6, 12, and 18 month timepoints of participation ]
- In turn, the effect of integrated risk reduction intervention on medical risk factors and on sleep/wake and social rhythm disturbances will be mediated by the regular participation and adherence of the subject to integrated risk reduction intervention. [ Time Frame: This is assessed by how many missed appointments the subject has for IRRI ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00746343
United States, Pennsylvania | |
Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | David J Kupfer, M.D. | University of Pittsburgh |
Responsible Party: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00746343 History of Changes |
Other Study ID Numbers: |
PRO08020071 R01MH081003 ( U.S. NIH Grant/Contract ) |
First Posted: | September 4, 2008 Key Record Dates |
Last Update Posted: | December 12, 2013 |
Last Verified: | December 2013 |
Keywords provided by University of Pittsburgh:
Bipolar I Disorder Medical Risks Integrated Risk Reduction Intervention Currently in Remission BMI |
Additional relevant MeSH terms:
Disease Bipolar Disorder Pathologic Processes Bipolar and Related Disorders Mental Disorders |