Relapse Prevention for Bipolar Type-II Disorder
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder; Depression
Intervention: Fluoxetine (Drug); Lithium (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: National Institute of Mental Health (NIMH)
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.
Clinical Details
Official title: Relapse Prevention of Bipolar Type-II Disorder
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Bipolar II Depression
Locations and Contacts
Depression Research Unit, Univ Penn, Philadelphia, Pennsylvania 19104, United States
Additional Information
Last updated: February 7, 2007
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