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.

Study Overview

• Status: Completed
• Conditions: Depression; Bipolar Disorder
• Intervention / Treatment: Drug: Fluoxetine; Drug: Lithium

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.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00602537

• Study Type: Interventional
• Enrollment: 180
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Depression Research Unit, Univ Penn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Bipolar II Depression

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute of Mental Health (NIMH)

Publications and helpful links

General Publications

• Amsterdam JD, Luo L, Shults J. Efficacy and mood conversion rate during long-term fluoxetine v. lithium monotherapy in rapid- and non-rapid-cycling bipolar II disorder. Br J Psychiatry. 2013 Apr;202(4):301-6. doi: 10.1192/bjp.bp.111.104711. Epub 2012 Oct 25.
• Amsterdam JD, Shults J. Efficacy and safety of long-term fluoxetine versus lithium monotherapy of bipolar II disorder: a randomized, double-blind, placebo-substitution study. Am J Psychiatry. 2010 Jul;167(7):792-800. doi: 10.1176/appi.ajp.2009.09020284. Epub 2010 Apr 1.

Study record dates

Study Major Dates

• Study Start: February 1, 2001
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: September 3, 2002
• First Submitted That Met QC Criteria: September 4, 2002
• First Posted (Estimate): September 5, 2002

Study Record Updates

• Last Update Posted (Estimate): October 6, 2015
• Last Update Submitted That Met QC Criteria: October 2, 2015
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Bipolar and Related Disorders; Bipolar Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Fluoxetine
• Other Study ID Numbers: R01MH060353-01 (U.S. NIH Grant/Contract); DSIR 83-ATP (NCT00719979)