Psychotherapy for Bipolar II Depression, Pilot Study, Phase II

NCT ID: NCT00411463

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2010-09-30

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 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.

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 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.

Conditions

Bipolar II Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Psychotherapy

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

Group Type: EXPERIMENTAL

Interpersonal and Social Rhythm Therapy (IPSRT-BPII)

Intervention Type: BEHAVIORAL

IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.

Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms.

Medication

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

Group Type: EXPERIMENTAL

Seroquel

Intervention Type: DRUG

Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day

Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.

This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.

Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder.

Interventions

Interpersonal and Social Rhythm Therapy (IPSRT-BPII)

IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.

Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning symptoms.

Intervention Type: BEHAVIORAL

Seroquel

Subjects will be started at 100 mg/day titrated to a maximum of 800 mg /day

Day 1-BID doses totaling 100 mg/day, increased to 400 mg/day on Day 4 in increments of up to 100 mg/day in BID divided doses, by Day 6 begin titration up to a maximum dose of 800 mg/day in increments no greater than 200 mg/day.

This titration schedule may be adjusted based on the subject's response and ability to tolerate Seroquel.

Subjects who are unable to tolerate the study medications, or for whom the study medications are an inappropriate clinical choice, will be treated openly by a clinic physician according to the standard of care guidelines designated by the American Psychiatric Association (2002) for the treatment of bipolar disorder.

Intervention Type: DRUG

Other Intervention Names

IPSRT; Quetiapine

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Alliance for Research on Schizophrenia and Depression

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Holly Swartz

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Holly Swartz, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh /University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Swartz HA, Frank E, Cheng Y. A randomized pilot study of psychotherapy and quetiapine for the acute treatment of bipolar II depression. Bipolar Disord. 2012 Mar;14(2):211-6. doi: 10.1111/j.1399-5618.2012.00988.x.

Reference Type: RESULT

PMID: 22420597 (View on PubMed)

Other Identifiers

0608080

Identifier Type: -

Identifier Source: org_study_id