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Prevention of Relapse & Recurrence of Bipolar Depression

Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder

Intervention: Lithium / Fluoxetine (Drug); Lithium / Placebo (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
Robert J. DeRubeis, PhD, Principal Investigator, Affiliation: University of Pennsylvania
John M Zajecka, MD, Principal Investigator, Affiliation: Rush University Medical Center

Summary

The purpose of this study is to determine whether the long-term use of combined antidepressant plus mood stabilizer therapy is superior to mood stabilizer therapy alone in preventing the relapse and recurrence of bipolar depression.

Clinical Details

Official title: Prevention of Relapse & Recurrence of Bipolar Depression

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Relapse or Recurrence of Major Depressive Episode

Secondary outcome:

Occurence of Manic Episodes

Occurence of Hypomanic Episodes

Occurence of Sub-Syndromal Mood Conversion Episodes

Detailed description: Recurrence of Bipolar I (BP I) major depressive episode (MDE), is now recognized as a major mental health problem. Recurrent BP I MDE is a disorder with no satisfactory therapy, and its treatment remains a challenge to clinicians. To date, initial and long-term therapy of BP I MDE has been based on un-validated practice guidelines. These guidelines recommend limiting antidepressant drug (AD) use during initial therapy of BP I MDE, and completely avoiding AD use during long-term therapy. There is, however, no empirical evidence to suggest that mood stabilizer (MS) monotherapy is superior to combined MS plus AD therapy in preventing recurrent BP I MDE. Nor is there evidence to suggest that long-term MS plus AD therapy results in more manic switch episodes. We present evidence that AD-induced mania during long-term therapy of BP I MDE has been over-estimated, and that long-term use of MS plus AD therapy may be superior to MS therapy alone in preventing recurrent BP I MDE. In this study, we will ask: "Does continuation therapy with combined lithium plus fluoxetine result in fewer MDE relapses and recurrences vs. lithium monotherapy?" To answer this question, patients with BP I MDE will receive combined lithium plus fluoxetine therapy for 8 weeks. Responders who stay well for an additional 4 weeks of consolidation therapy will then be randomized to double-blind continuation therapy with either (i) combined lithium plus fluoxetine, or (ii) lithium alone (following fluoxetine taper and discontinuation) for an additional 50 weeks. We hypothesize that long-term lithium plus fluoxetine therapy will result in fewer MDE relapses and recurrences vs. lithium monotherapy. We will also ask: "What is the relative safety, tolerability, and frequency of syndromal and sub-syndromal manic, hypomanic, and mixed state conversions during continuation treatment with combined lithium plus fluoxetine vs. lithium monotherapy?" To answer this question, we will measure: the frequency, severity, and duration of syndromal and sub-syndromal manic, hypomanic, and mixed state conversions; frequency, severity, and duration of treatment-emergent adverse events; frequency of treatment discontinuation; time to onset of first syndromal and sub-syndromal conversion event; time to first treatment intervention of each syndromal and sub-syndromal conversion event; and, time to onset of increase in suicidal ideation event. We hypothesize that lithium plus fluoxetine therapy will result in a similar frequency of syndromal and sub-syndromal conversion events, and a similar frequency of treatment-emergent adverse events. We further hypothesize that lithium plus fluoxetine therapy will result in fewer suicide ideation events and fewer study discontinuations vs. lithium monotherapy. We believe that the results of this trial may have an important public health impact on the current practice guidelines for treating BP I MDE.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men/women (all races and ethnicity)

- Age at least 18 years old

- Bipolar Type I Disorder

- Current Major Depressive Episode

- Able to understand and provide signed informed consent

Exclusion Criteria:

- Current alcohol or drug abuse

- Alcohol or drug dependence within 3 months

- Allergic to Fluoxetine or Lithium

- Unstable medical condition (e. g., uncontrolled thyroid, renal, cardiovascular

disease)

- Pregnant or nursing women

- Women of child-bearing potential unwilling to use a medically acceptable form of

contraception

- Actively suicidal

- Requiring hospitalization

- Use of medication contraindicated with lithium or fluoxetine

- Unable to participate in a year-long trial

Locations and Contacts

Rush University Medical Center, Chicago, Illinois 60612, United States

Depression Research Unit, Philadelphia, Pennsylvania 19104-3309, United States

Additional Information

Depression Research Unit

Starting date: July 2009
Last updated: July 22, 2014

Page last updated: August 23, 2015

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