Psychotherapy for Bipolar II Depression, Pilot Study, Phase II

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Holly Swartz, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00411463
First received: December 12, 2006
Last updated: January 20, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Bipolar II Disorder
Behavioral: Interpersonal and Social Rhythm Therapy (IPSRT-BPII)
Drug: Seroquel
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Psychotherapy for Bipolar II Depression, Pilot Study, Phase II

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Change on measures of depression and anxiety (Hamilton Rating Scale for Depression 25-item score (HRSD-25) and the Young Mania Rating Scale (YMRS) [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
  • quality of life (QOL). [ Time Frame: Week 20 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Descriptive measures of the feasibility of IPSRT-BPII [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: December 2006
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psychotherapy
Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII)
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.

Experimental: Medication
Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine)
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.


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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411463

Locations
United States, Pennsylvania
University of Pittsburgh /University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Holly Swartz, M.D. University of Pittsburgh
  More Information

No publications provided

Responsible Party: Holly Swartz, Associate Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00411463     History of Changes
Other Study ID Numbers: 0608080
Study First Received: December 12, 2006
Last Updated: January 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Interpersonal Therapy
Social Rhythm Therapy
Bipolar Disorder
Depression
Seroquel

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 29, 2014