Reducing Medical Risks in Individuals With Bipolar Disorder - Full Study (NCT00746343) | Clinical Trial Compass
CompletedNot Applicable
Reducing Medical Risks in Individuals With Bipolar Disorder - Full Study
United States122 participantsStarted 2008-09
Plain-language 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. We will examine the role of behavioral risk factors and presumed behavioral mediators and moderators of health risk in individuals suffering from bipolar I disorder. The investigators will employ an innovative behavioral intervention with guideline based psychiatric care ( Integrated Risk Reduction Intervention - IRRI) in order to target modifiable medical risk factors.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Exclusion criteria
. Ultra-rapid cycling (\>8 episodes per year) bipolar I disorder
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: Entry and every 6 months of participation for two years
2
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.
Timeframe: Entry and every 6 months of participation for two years
. 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