Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT01085812|
Recruitment Status : Completed
First Posted : March 12, 2010
Results First Posted : January 13, 2020
Last Update Posted : January 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Depression Major Depressive Disorder||Drug: Levomilnacipran ER Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||734 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 Levomilnacipran ER capsules, oral administration, once daily dosing.
Drug: Levomilnacipran ER
Drug: Levomilnacipran ER (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.
- Time to Relapse (Days) [ Time Frame: 24 Weeks ]Number of days until patients meet relapse criteria. Relapse was defined as 1 or more of the following: 1. MADRS total score of at least 22 at 2 consecutive visits 2. Increase of 2 or more points in CGI-I score compared with the CGI-I score at Visit 9 at 2 consecutive visits 3. Premature discontinuation due to insufficient therapeutic response 4. MADRS item 10 score of at least 4
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
|Study Director:||Giovanna Forero, MA||Forest Laboratories|