Clinical trial NCT00411463: Psychotherapy for Bipolar II Depression, Pilot Study, Phase II
Official title: Psychotherapy for Bipolar II Depression, Pilot Study, Phase II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Bipolar II Disorder
Keywords: Interpersonal Therapy
Social Rhythm Therapy
Bipolar Disorder
Depression
Seroquel
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2006-12-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With Greater Than or Equal to 50% Reduction in Depression Scores, With a Mania Score Less Than or Equal to 10
timeFrame: Week 12
Secondary outcomes:
measure: Quality of Life (QOL) Collected Using the Q-LES-Q (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form)
timeFrame: Baseline and Week 12
measure: Descriptive Measures of the Feasibility of IPSRT-BPII
timeFrame: Week 12
measure: Number of Participants With a Response
timeFrame: Week 12
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh /University of Pittsburgh Medical Center (UPMC)
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Holly Swartz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.