NCT00227968

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 1995

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1995

Completed
7.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
Last Updated

June 25, 2013

Status Verified

June 1, 2013

First QC Date

September 26, 2005

Last Update Submit

June 21, 2013

Conditions

Bipolar Disorder

Keywords

Manic-depressive psychosisDepression, bipolar

Outcome Measures

Primary Outcomes (1)

  • Time to stabilization in the acute phase and time to recurrence in the maintenance phase

Secondary Outcomes (1)

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

Interventions

Interpersonal Social Rhythm Therapy (IPSRT)BEHAVIORAL
Clinical Status and Symptom Response Therapy (CSSRT)BEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

  • Mallinger AG, Frank E, Thase ME, Barwell MM, Diazgranados N, Luckenbaugh DA, Kupfer DJ. Revisiting the effectiveness of standard antidepressants in bipolar disorder: are monoamine oxidase inhibitors superior? Psychopharmacol Bull. 2009;42(2):64-74.

    PMID: 19629023DERIVED

  • Frank E, Soreca I, Swartz HA, Fagiolini AM, Mallinger AG, Thase ME, Grochocinski VJ, Houck PR, Kupfer DJ. The role of interpersonal and social rhythm therapy in improving occupational functioning in patients with bipolar I disorder. Am J Psychiatry. 2008 Dec;165(12):1559-65. doi: 10.1176/appi.ajp.2008.07121953. Epub 2008 Oct 1.

    PMID: 18829872DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Ellen Frank, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 26, 2005

First Posted

September 28, 2005

Study Start

March 1, 1995

Study Completion

April 1, 2002

Last Updated

June 25, 2013

Record last verified: 2013-06

Locations

US(1)