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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) |
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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
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
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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