Psychosocial Therapy Plus Maintenance Pharmacotherapy for Treating Bipolar Disorder

Phase 4

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT00227968
• Lead Sponsor: University of Pittsburgh

Brief Summary

This study will evaluate the effectiveness of interpersonal and social rhythm therapy (IPSRT) versus clinical status and symptom response therapy (CSSRT) in reinforcing the treatment of bipolar disorder in individuals who are currently undergoing medication treatment for the disorder.

Detailed Description

Bipolar disorder is a serious medical illness that causes shifts in a person's mood, energy, and ability to function. These changes are drastic, and can result in damaged relationships, poor job or school performance, and suicide. Bipolar disorder is also known as manic-depressive disorder because it is characterized by episodes of mania and depression. Some signs and symptoms of a manic episode include the following: increased energy, activity, and restlessness; excessively "high," overly good mood; and extreme irritability. Some signs and symptoms of a depressive episode include the following: sad, anxious, or empty mood; feelings of hopelessness or pessimism; and feelings of guilt, worthlessness, or helplessness. Bipolar disorder is most effectively treated using a strategy that combines medication and psychosocial treatment. This study will evaluate the effectiveness of IPSRT versus CSSRT in reinforcing the treatment of bipolar disorder in individuals who are currently undergoing maintenance medication treatment for the disorder.

Participants in this open-label study will be randomly assigned to one of two treatment strategies: IPSRT or CSSRT. All participants will attend study visits once a week until they have been stable for 4 weeks (acute phase). At this point, they will attend study visits every other week for 12 weeks (continuation phase), and then once a month for 18 months or until another depressive or mixed episode occurs (maintenance phase). Participants who experience a recurrence will be treated with medication and the type of therapy they were assigned upon study entry (IPSRT or CSSRT). These participants will continue to be followed for a period of time equivalent to their remainder of time in the study had they not experienced a recurrence. Outcomes will be measured at Week 12 of the continuation phase and Week 18 of the maintenance phase.

Study Timeline

• Study Start: 1995-03
• Study Completion: 2002-04
• Study First Submitted: 2005-09-26
• Study First Submitted QC: 2005-09-26
• Study First Posted: 2005-09-28
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-21
• Last Update Posted: 2013-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

Inclusion Criteria

• Diagnosis of bipolar disorder
• Currently in the third episode of mania or major depression
• History of one other episode of major depression within 5 years prior to study entry

Exclusion Criteria

• Currently in the first episode of mania or schizo-affective disorder (manic type)
• Rapid cycling drug or alcohol abuse
• Unstable medical illness
• Pregnant
• Index episode caused by medically prescribed drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Time to stabilization in the acute phase and time to recurrence in the maintenance phase

Secondary Outcome Measures

Name	Time	Method
Measured at Week 12 of the continuation phase and Week 18 of the maintenance phase: Somatic Symptoms Checklist

Trial Locations

Locations (1)

Western Psychiatric Institute and Clinic; 🇺🇸 Pittsburgh, Pennsylvania, United States