Status:
COMPLETED
Psychotherapy for Bipolar II Depression, Pilot Study, Phase II
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Alliance for Research on Schizophrenia and Depression
Conditions:
Bipolar II Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
Purpose of this study is to examine the effectiveness of an experimental psychotherapy (talk therapy) for the treatment of bipolar II depression. The name of this psychotherapy is Interpersonal and So...
Detailed Description
The proposed pilot study is an experimental design intended to investigate the preliminary efficacy of Interpersonal Social Rhythm Therapy for Bipolar II Depression (IPSRT-BPII). A total of 56 eligibl...
Eligibility Criteria
Inclusion
- Meets DSM-IV Criteria for Bipolar Disorder, Type II, currently depressed;
- HRSD-25 ≥15
- Age 18-65 years;
- Able to give informed consent;
- Women of child bearing potential will be included if they agree to use adequate contraception for the duration of the study.
Exclusion
- Not competent to give informed consent in the opinion of the investigator (e.g., psychotic at time of evaluation);
- Unwilling or unable to comply with study requirements;
- Meets DSM-IV criteria for borderline personality disorder or antisocial personality disorder;
- Active substance abuse within the past 6 months(episodic abuse related to mood episodes will not exclude a subject);
- Currently a high suicide risk, as assessed by an active plan and intent to behave in a way that risks ending ones life;
- Non-English speaking;
- Significant, unstable, medical illness that might confound symptom scores or preclude treatment with pharmacotherapy
- Currently applying for disability because of psychiatric illness (we have found that these individuals have a vested interested in appearing to remain ill which potentially confounds outcome scores).
- Women who are pregnant, lactating or plan to become pregnant during their study participation.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00411463
Start Date
December 1 2006
End Date
September 1 2010
Last Update
May 30 2017
Active Locations (1)
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1
University of Pittsburgh /University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States, 15213