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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01085812 |
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Date of registration:
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10/03/2010 |
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Primary sponsor: |
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Public title:
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Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder
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Scientific title:
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A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder |
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Date of first enrolment:
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March 2010 |
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Target sample size:
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348 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01085812 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Giovanna Forero, MA |
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Address:
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Telephone:
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Email:
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Affiliation:
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Forest Laboratories |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Men and women, 18-65 years old
- Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
- The patient's current depressive episode must be at least 4 weeks in duration
Exclusion Criteria:
- Women who are pregnant, women who will be breastfeeding during the study, and women
with childbearing potential who are not practicing a reliable method of birth control
- Patients with a history of meeting DSM-IV-TR criteria for:
- any manic or hypomanic episode
- schizophrenia or any other psychotic disorder
- obsessive-compulsive disorder
- Patients who are considered a suicide risk
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Depression
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Major Depressive Disorder
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Intervention(s)
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Drug: F2695 SR
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Drug: Placebo
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Primary Outcome(s)
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The primary outcome measure is the time to relapse (in days) during the double-blind treatment phase
[Time Frame: 24 Weeks]
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Secondary ID(s)
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LVM-MD-05
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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