Prevention of Relapse & Recurrence of Bipolar Depression

NCT00961961 | Completed Phase 4 Results DMC

• 2 other identifiers: R01MH080097R01MH080098
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder; Manic Depression; Major Depressive Episode; Mania; Hypomania; Long Term Treatment

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Relapse of Major Depressive Episode Within 1 Year

  Patients who were randomized to one of the Phase II conditions were interviewed once each month. If they met criteria for a relapse of a Major Depressive Episode, this was considered the study outcome. If they participated for the full year of Phase II without a documented relapse, they were considered a completer.

  1 year

Secondary Outcomes (3)

• Number of Participants With an Onset of a Manic Episode Within 1 Year

  1 Year

• Number of Participants With an Onset of a Hypomanic Episode Within 1 Year

  1 Year

• Number of Participants With the Onset of a Sub-Syndromal Mood Conversion Episode Within 1 Year

  1 Year

Study Arms (4)

Lithium plus Fluoxetine Phase I

OTHER

All participants were started in this arm. Those who met criteria for entry into Phase II were then randomized to one of the two Phase II arms.

Drug: Lithium / Fluoxetine

Lithium plus Placebo Phase I

OTHER

No participants began their participation on Lithium plus Placebo.

Drug: Lithium / Placebo

Lithium plus Fluoxetine Phase II

EXPERIMENTAL

Patients who responded to Lithium plus Fluoxetine in Phase I and were randomized to continue on both compounds.

Drug: Lithium / Fluoxetine

Lithium plus Placebo Phase II

PLACEBO COMPARATOR

Patients who responded to Lithium plus Fluoxetine in Phase I and were randomized to switch from Fluoxetine to placebo.

Drug: Lithium / Placebo

Interventions

Lithium / Fluoxetine DRUG

Individualized Daily Dosage

Also known as: Lithium Carbonate / Prozac

Lithium plus Fluoxetine Phase I; Lithium plus Fluoxetine Phase II

Lithium / Placebo DRUG

Individualized Daily Dosage

Also known as: Lithium Carbonate / Sugar Pill

Lithium plus Placebo Phase I; Lithium plus Placebo Phase II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Depression Research Unit

Philadelphia, Pennsylvania, 19104-3309, United States

Location

Related Links

• DeRubeis Lab Web Page

MeSH Terms

Conditions

Bipolar Disorder; Mania

Interventions

Lithium; Fluoxetine; Lithium Carbonate; Sugars

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Propylamines; Amines; Organic Chemicals; Carbonates; Alkalies; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds; Carbohydrates

Results Point of Contact

• Title: Dr. Robert J. DeRubeis
• Organization: UPenn

derubeis@psych.upenn.edu

215-573-5804

Study Officials

• Robert J. DeRubeis, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• John M Zajecka, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2009
• First Posted: August 19, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 19, 2020
• Results First Posted: October 19, 2020

Record last verified: 2020-09

Locations

US (2)