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Relapse Prevention for Bipolar Type-II Disorder

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

The purpose of this study is to determine the safety and effectiveness of fluoxetine (Prozac) in treating and preventing recurrent bipolar (manic depressive) type II episodes.

Condition Treatment or Intervention Phase
Bipolar Disorder
Depression
 Drug: Fluoxetine
 Drug: Lithium
Phase IV

MedlinePlus related topics:  Bipolar Disorder;   Depression

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Relapse Prevention of Bipolar Type-II Disorder

Further Study Details: 

Expected Total Enrollment:  180

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:


Location and Contact Information


Pennsylvania
      Depression Research Unit, Univ Penn, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Jay D Amsterdam, MD  215-662-3462    jamsterd@mail.med.upenn.edu 
Maryanne Giampapa, BA  215-662-2835    mgiampap@mail.med.upenn.edu 
Jay D Amsterdam, MD,  Principal Investigator

More Information

Study ID Numbers:  60353-01A2
Record last reviewed:  August 2004
Record first received:  September 3, 2002
ClinicalTrials.gov Identifier:  NCT00044616
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-27
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