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Relapse Prevention for Bipolar Type-II Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00044616
First received: September 3, 2002
Last updated: December 17, 2013
Last verified: December 2013

September 3, 2002
December 17, 2013
February 2001
January 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00044616 on ClinicalTrials.gov Archive Site
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Relapse Prevention for Bipolar Type-II Disorder
Relapse Prevention of Bipolar Type-II Disorder

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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Bipolar Disorder
  • Depression
  • Drug: Fluoxetine
  • Drug: Lithium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
January 2007
January 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Bipolar II Depression
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00044616
R01 MH060353-01, R01MH060353-01, DSIR 83-ATP
Not Provided
Not Provided
University of Pennsylvania
National Institute of Mental Health (NIMH)
Not Provided
University of Pennsylvania
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP