Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder
|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|
|Primary Completion Date :||October 2011|
|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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085812
Show 35 Study Locations
|Study Director:||Giovanna Forero, MA||Forest Laboratories|