Relapse Prevention for Bipolar Type-II Disorder

University of Pennsylvania

Status and phase

Completed

Phase 4

Conditions

Bipolar Disorder

Depression

Treatments

Drug: Fluoxetine

Drug: Lithium

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00044616

R01MH060353-01 (U.S. NIH Grant/Contract)

DSIR 83-ATP

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: