Psychotherapy for Bipolar II Depression, Pilot Study, Phase II

University of Pittsburgh

Status and phase: Completed; Phase 3; Phase 2

Conditions: Bipolar II Disorder

Treatments: Drug: Seroquel; Behavioral: Interpersonal and Social Rhythm Therapy (IPSRT-BPII)

Study type: Interventional

Funder types: Other

Identifiers

NCT00411463

0608080

Details and patient eligibility

About

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.

Full 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 eligible subjects with a diagnosis of bipolar II disorder will be randomly assigned to one of two treatment groups : Seroquel (n=28) or IPSRT-BPII (n=28). Following baseline assessment, all participants will undergo up to 20 weeks of their assigned treatment. Patients assigned to IPSRT-BPII who fail to respond (at least 50% reduction in HRSD-25 scores and YMRS ≤ 10) by week 12 will have Seroquel added to IPSRT-BPII. Subjects who achieve remission (defined as 3 consecutive weeks where both HRSD-25 and YMRS scores average ≤ 7) and have participated in the trial for a minimum of 12 weeks will be moved into a continuation phase where they will receive maintenance treatment (bi-monthly therapy sessions and/or pharmacotherapy) until week 20. Patients who do not achieve remission by Week 20 will be discontinued from treatment and referred for follow-up care. All subjects (remitters and non-remitters) will be assessed at 20 weeks.

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Psychotherapy

Experimental group

Description:

Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)

Treatment:

Behavioral: Interpersonal and Social Rhythm Therapy (IPSRT-BPII)

Medication

Experimental group

Description:

Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)

Treatment:

Drug: Seroquel