Psychotherapy for Bipolar II Depression, Pilot Study, Phase II - Full Text View

Sponsors and Collaborators:	University of Pittsburgh National Alliance for Research on Schizophrenia and Depression
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00411463

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 32 weeks.

Condition	Intervention	Phase
Bipolar II Disorder	Behavioral: Interpersonal and Socail Rhythm Therapy (IPSRT) Drug: Seroquel	Phase II Phase III

MedlinePlus related topics: Depression

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Psychotherapy for Bipolar II Depression, Pilot Study, Phase II

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Change on measures of depression and anxiety (HRSD),
quality of life (QOL).

Secondary Outcome Measures:

Descriptive measures of the feasiblity of IPSRT-BPII

Estimated Enrollment:	36
Study Start Date:	December 2006
Estimated Study Completion Date:	February 2008

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 36 eligible subjects with a diagnosis of bipolar II disorder will be randomly assigned to one of two treatment groups : Seroquel (n=18) or IPSRT-BPII (n=18). Following baseline assessment, all participants will undergo up to 32 weeks of their assigned treatment.

Patients assigned to IPSRT-BPII who fail to respond (at least 50% reduction in HRSD-25 scores and YMRS < or = 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 < or = 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 32. Patients who do not achieve remission by Week 32 will be discontinued from treatment and referred for follow-up care. All subjects (remitters and non-remitters) will be assessed at 32 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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;
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.

Contacts and Locations

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

Contacts

Contact: Joan Buttenfield, BSN

412-246-5566

Locations

United States, Pennsylvania
University of Pittsburgh /University of Pittsburgh Medical Center (UPMC)	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Swartz Holly, M.D.
Sub-Investigator: Ellen Frank, Ph.D.
Sub-Investigator: Jill Cyranowski, Ph.D.
Sub-Investigator: Andrea Fagiolini, M.D.
Sub-Investigator: Isabella Soreca, M.D.

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

Study ID Numbers:	0608080
Study First Received:	December 12, 2006
Last Updated:	December 13, 2006
ClinicalTrials.gov Identifier:	NCT00411463 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Interpersonal Therapy
Social Rhythm Therapy
Bipolar Disorder
Depression
Seroquel

Study placed in the following topic categories:

Quetiapine
Tranquilizing Agents
Depression
Mental Disorders
Bipolar Disorder
Psychotropic Drugs

Mood Disorders
Central Nervous System Depressants
Antipsychotic Agents
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Depression
Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Depressive Disorder
Antipsychotic Agents

Pharmacologic Actions
Behavioral Symptoms
Quetiapine
Mental Disorders
Therapeutic Uses
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 06, 2009