Psychotherapy for Bipolar II Depression, Pilot Study, Phase II

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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 Social Rhythm Therapy for Bipolar II Depression (IPSRT-BPII). Subjects will be randomly assigned to receive either IPSRT-BPII or the medication Seroquel (quetiapine) to manage their symptoms of bipolar II depression. Subjects will receive the assigned therapy for up to 20 weeks.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: National Alliance for Research on Schizophrenia and Depression
• Treatments: Quetiapine Fumarate

Criteria

Inclusion Criteria:

1. Meets DSM-IV Criteria for Bipolar Disorder, Type II, currently depressed;

2. HRSD-25 ≥15

3. Age 18-65 years;

4. Able to give informed consent;

5. Women of child bearing potential will be included if they agree to use adequate contraception for the duration of the study.

Exclusion Criteria:

1. Not competent to give informed consent in the opinion of the investigator (e.g., psychotic at time of evaluation);

2. Unwilling or unable to comply with study requirements;

3. Meets DSM-IV criteria for borderline personality disorder or antisocial personality disorder;

4. Active substance abuse within the past 6 months(episodic abuse related to mood episodes will not exclude a subject);

5. Currently a high suicide risk, as assessed by an active plan and intent to behave in a way that risks ending ones life;

6. Non-English speaking;

7. Significant, unstable, medical illness that might confound symptom scores or preclude treatment with pharmacotherapy

8. 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).

9. Women who are pregnant, lactating or plan to become pregnant during their study participation.