Psychotherapy for Bipolar II Depression, Pilot Study, Phase II

Bipolar II Disorder Clinical Trial

Official title:

Psychotherapy for Bipolar II Depression, Pilot Study, Phase II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00411463
• Other study ID #: 0608080
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 12, 2006
• Last updated: January 20, 2013
• Start date: December 2006
• Est. completion date: September 2010

Study information

• Verified date: January 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar II Disorder

Intervention

Behavioral:
• 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.

Drug:
• 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. Subjects receiving standard of care treatment will continue to be seen and assessed per the protocol schedule.

Locations

Country	Name	City	State
United States	University of Pittsburgh /University of Pittsburgh Medical Center (UPMC)	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change on measures of depression and anxiety (Hamilton Rating Scale for Depression 25-item score (HRSD-25) and the Young Mania Rating Scale (YMRS)		Week 20	No
Primary	quality of life (QOL).		Week 20	No
Secondary	Descriptive measures of the feasibility of IPSRT-BPII		Week 20	No
Secondary	Subjects will be evaluated for a response to treatment. Response is defined as an average of 50% (or greater) reduction in the subject's baseline HRSD-25 score over three consecutive weeks and a current YMRS score = 10		Week 12	No