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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00961961 |
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Date of registration:
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18/08/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Prevention of Relapse & Recurrence of Bipolar Depression
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Scientific title:
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Prevention of Relapse & Recurrence of Bipolar Depression |
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Date of first enrolment:
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July 1, 2009 |
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Target sample size:
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177 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00961961 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Robert J. DeRubeis, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pennsylvania |
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Name:
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John M Zajecka, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rush University Medical Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Bipolar Disorder
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Intervention(s)
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Drug: Lithium / Fluoxetine
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Drug: Lithium / Placebo
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Primary Outcome(s)
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Number of Participants With Relapse of Major Depressive Episode Within 1 Year
[Time Frame: 1 year]
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Secondary Outcome(s)
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Number of Participants With an Onset of a Manic Episode Within 1 Year
[Time Frame: 1 Year]
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Number of Participants With an Onset of a Hypomanic Episode Within 1 Year
[Time Frame: 1 Year]
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Number of Participants With the Onset of a Sub-Syndromal Mood Conversion Episode Within 1 Year
[Time Frame: 1 Year]
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Secondary ID(s)
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R01MH080098
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R01MH080097
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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