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Relapse Prevention for Bipolar Type-II Disorder

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT00044616
Collaborator
National Institute of Mental Health (NIMH) (NIH)
180
Enrollment
1
Location
71
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This 62-week study will compare the safety and effectiveness of fluoxetine (Prozac®), lithium, the combination of these two medications, and placebo in treating and preventing recurrent depressive episodes in people with bipolar type II disorder.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Bipolar II (BP II) disorder is characterized by a high recurrence of major depressive episodes (MDE), and it is associated with substantial illness and deaths. Unfortunately, relatively little attention has been given to treatment of BP II. Concern that patients may switch from depressed to manic states during treatment of MDE has impeded the development of effective treatments for BP II MDE.

BP II MDE patients are treated initially with fluoxetine for 10 weeks. Patients who recover from MDE are then randomized to receive a relapse-prevention treatment of fluoxetine, lithium, a combination of fluoxetine and lithium, or placebo for 1 year. Patients undergo clinical and laboratory evaluations, including physical examinations, bloodwork, thyroid function tests, electrocardiogram (ECG), urinalysis, and HAM-D, YMR, CGI-S, CGI-I, and adverse events scales.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00602537

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Relapse Prevention of Bipolar Type-II Disorder
Study Start Date :
Feb 1, 2001
Actual Primary Completion Date :
Jan 1, 2007
Actual Study Completion Date :
Jan 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Bipolar II Depression

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Depression Research Unit, Univ Penn Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • University of Pennsylvania
    • National Institute of Mental Health (NIMH)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT00044616
    Other Study ID Numbers:
    • R01MH060353-01
    • R01MH060353-01
    • DSIR 83-ATP
    First Posted:
    Sep 5, 2002
    Last Update Posted:
    Oct 6, 2015
    Last Verified:
    Dec 1, 2013
    Additional relevant MeSH terms:
    Bipolar Disorder
    Fluoxetine

    Study Results

    No Results Posted as of Oct 6, 2015