Psychosocial Therapy Plus Maintenance Pharmacotherapy for Treating Bipolar Disorder

This study has been completed.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00227968
First received: September 26, 2005
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Behavioral: Interpersonal Social Rhythm Therapy (IPSRT)
Behavioral: Clinical Status and Symptom Response Therapy (CSSRT)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Maintenance Therapies in Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Time to stabilization in the acute phase and time to recurrence in the maintenance phase

Secondary Outcome Measures:
  • Measured at Week 12 of the continuation phase and Week 18 of the maintenance phase: Somatic Symptoms Checklist

Estimated Enrollment: 181
Study Start Date: March 1995
Estimated Study Completion Date: April 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227968

Locations
United States, Pennsylvania
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Ellen Frank, PhD University of Pittsburgh
  More Information

No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00227968     History of Changes
Other Study ID Numbers: R37 MH29618-95, 950310
Study First Received: September 26, 2005
Last Updated: June 21, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Manic-depressive psychosis
Depression, bipolar

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014