Psychotherapy for Bipolar II Depression, Pilot Study, Phase II

NCT00411463 | Completed Phase 2 Results

• 1 other identifier: 0608080
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar II Disorder

Keywords

Interpersonal Therapy; Social Rhythm Therapy; Bipolar Disorder; Depression; Seroquel

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Greater Than or Equal to 50% Reduction in Depression Scores, With a Mania Score Less Than or Equal to 10

  Overall response rates (defined as greater than or equal to 50% reduction in depression scores without an increase in mania scores) were 29% (n=4) in the IPSRT group and 27% (n=3) in the quetiapine group. HRSD-25 scores are based on first 17 responses. Eight items are scored on a 5-pt scale, from 0 (not present) to 4 (severe.) Other nine items on the assessment are scored from 0-2. The higher the score on the HRSD-25, the worse the outcome is considered to be. A score of 0-7 is considered to be normal; 8-13 indicates mild depression, 14-18 indicates moderate depression, 19-22 indicates severe depression, and any score greater than or equal to 23 indicates very severe depression. The YMRS is an 11 point assessment. There are 4 items assessed on a scale ranging from 0 to 8 and the other 7 items are graded on a 0 to 4 scale. As with the HRSD, the higher the score on the YMRS indicates the presence of more or more severe manic symptoms and is associated with a worse outcome.

  Week 12

Secondary Outcomes (3)

• Quality of Life (QOL) Collected Using the Q-LES-Q (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form)

  Baseline and Week 12

• Descriptive Measures of the Feasibility of IPSRT-BPII

  Week 12

• Number of Participants With a Response

  Week 12

Study Arms (2)

Psychotherapy

EXPERIMENTAL

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

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

Medication

EXPERIMENTAL

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

Drug: Seroquel

Interventions

Interpersonal and Social Rhythm Therapy (IPSRT-BPII) 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.

Also known as: IPSRT

Psychotherapy

Seroquel 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.

Also known as: Quetiapine

Medication

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets DSM-IV Criteria for Bipolar Disorder, Type II, currently depressed;
• HRSD-25 ≥15
• Age 18-65 years;
• Able to give informed consent;
• Women of child bearing potential will be included if they agree to use adequate contraception for the duration of the study.

You may not qualify if:

• Not competent to give informed consent in the opinion of the investigator (e.g., psychotic at time of evaluation);
• Unwilling or unable to comply with study requirements;
• Meets DSM-IV criteria for borderline personality disorder or antisocial personality disorder;
• Active substance abuse within the past 6 months(episodic abuse related to mood episodes will not exclude a subject);
• Currently a high suicide risk, as assessed by an active plan and intent to behave in a way that risks ending ones life;
• Non-English speaking;
• Significant, unstable, medical illness that might confound symptom scores or preclude treatment with pharmacotherapy
• 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).
• Women who are pregnant, lactating or plan to become pregnant during their study participation.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

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

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 22420597 RESULT

MeSH Terms

Conditions

Bipolar Disorder; Depression

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Holly Swartz, MD
• Organization: University of Pittsburgh

swartzha@upmc.edu

412-246-5588

Study Officials

• Holly Swartz, M.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: December 12, 2006
• First Posted: December 14, 2006
• Study Start: December 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 30, 2017
• Results First Posted: April 19, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)