Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 time providing optimal psychiatric care and medical monitoring. This will allow us to investigate the role that improvements in sleep/wake and social rhythm regularity, diet, and physical activity have in improving psychiatric and functional outcomes. In order to examine another set or possible pathways (i.e., that it is the amelioration or psychiatric symptoms that leads to the improvements in physical health), we will contrast outcomes of subjects receiving IRRI with those of subjects receiving psychiatric care with medical monitoring (PCMM), which incorporates the same optimal psychiatric care plus monitoring of medical conditions. These aims will be achieved in a 24-month randomized treatment trial of 144 adult subjects with bipolar I disorder. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00746343
Study type Interventional
Source University of Pittsburgh
Contact
Status Completed
Phase N/A
Start date September 2008
Completion date September 2013

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03641300 - Efficacy of Convulsive Therapies for Bipolar Depression N/A
Withdrawn NCT01495156 - Study of the Efficacy of Adjunctive Lithium Treatment for the Treatment of Psychotic Mania Phase 4
Completed NCT00982020 - Study in Adolescents With Schizophrenia or Bipolar Disorder Phase 4
Completed NCT00177463 - L-Carnosine for Bipolar I Disorder N/A
Completed NCT03257865 - A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes, Associated With Bipolar I Disorder Phase 3
Completed NCT03259555 - A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder Phase 3
Not yet recruiting NCT06433635 - Sequential Multiple Assignment Randomized Trial for Bipolar Depression Phase 4
Completed NCT04127058 - Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia Phase 1
Recruiting NCT05977023 - NMDA Receptor Modulation for the Treatment of Bipolar I Disorder Phase 2
Recruiting NCT05340686 - Braining- Aerobic Physical Activity as Add on Treatment in Bipolar Depression N/A
Completed NCT03287869 - A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder. Phase 3
Enrolling by invitation NCT04987229 - Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects Phase 3
Completed NCT00761761 - Sensoril(Ashwaganhda)for Bipolar Disorder Phase 3
Completed NCT00232414 - A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression in Adolescents With Bipolar Disorder Phase 3
Completed NCT03292848 - Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders Phase 1
Active, not recruiting NCT04561622 - Emotional Proactive Processing in Bipolar Disorder
Recruiting NCT03943537 - Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders Phase 2
Completed NCT03334721 - Gabapentin for Bipolar & Cannabis Use Disorders Phase 2
Active, not recruiting NCT05658510 - Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III) Phase 3
Completed NCT00958633 - Mood Stabilizer (MS)+ Antidepressant vs MS + Placebo in Maintenance of Bipolar Disorder. Phase 3