Premenstrual Dysphoric Disorder |
Pmdd; Premenstrual Dysphoric Disorder (pmdd) |
Clinical Trial: Relapse Prevention for Bipolar Type-II Disorder
This study is currently recruiting patients.
|
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:
- Bipolar II Depression
Location and Contact Information
Pennsylvania
Depression Research Unit, Univ Penn, Philadelphia, Pennsylvania, 19104, United States; Recruiting
Maryanne Giampapa, BA 215-662-2835 mgiampap@mail.med.upenn.edu
Jay D Amsterdam, MD, Principal Investigator
More Information
Record last reviewed: February 2005
Last Updated: February 23, 2005
Record first received: September 3, 2002
ClinicalTrials.gov Identifier: NCT00044616
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- PMS and PMDD (Cleveland Clinic)
- Premenstrual Dysphoric Disorder (National Women's Health Information Center)

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