Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT01085812|
Recruitment Status : Completed
First Posted : March 12, 2010
Last Update Posted : January 4, 2012
|Condition or disease||Intervention/treatment||Phase|
|Depression Major Depressive Disorder||Drug: F2695 SR Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||348 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
40, 80 or 120 mg/day F2695 SR capsules, oral administration, once daily dosing.
Drug: F2695 SR
Drug: F2695 SR (40, 80 or 120 mg/day) Study drug is to be given orally, in capsule form, once daily.
Placebo Comparator: 1
Matching placebo capsules, oral administration, once daily dosing.
Matching placebo to be given orally, in capsule form, once daily.
- The primary outcome measure is the time to relapse (in days) during the double-blind treatment phase [ Time Frame: 24 Weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085812
Show 35 Study Locations
|Study Director:||Giovanna Forero, MA||Forest Laboratories|