Psychosocial Therapy Plus Maintenance Pharmacotherapy for Treating Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Maintenance Therapies in Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00227968
• Other study ID #: R37 MH29618-95
• Secondary ID: 950310
• Status: Completed
• Phase: Phase 4
• First received: September 26, 2005
• Last updated: June 21, 2013
• Start date: March 1995
• Est. completion date: April 2002

Study information

• Verified date: June 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: April 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Behavioral:
• Interpersonal Social Rhythm Therapy (IPSRT)

• Clinical Status and Symptom Response Therapy (CSSRT)

Locations

Country	Name	City	State
United States	Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to stabilization in the acute phase and time to recurrence in the maintenance phase
Secondary	Measured at Week 12 of the continuation phase and Week 18 of the maintenance phase: Somatic Symptoms Checklist