Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT01034462|
Recruitment Status : Completed
First Posted : December 17, 2009
Results First Posted : October 25, 2013
Last Update Posted : October 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Levomilnacipran ER Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||442 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind, Placebo-Controlled, Flexible-Dose Study of F2695 SR in Patients With Major Depressive Disorder|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing.
Drug: Levomilnacipran ER
Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing. Study drug is to be given orally, in capsule form, once daily, for 8 weeks
Placebo Comparator: 2
Matching placebo capsules, oral administration, once daily dosing.
Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: From Baseline to Week 8 ]
MADRS was used to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest.
Each item of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 60 (maximum severity).
- Change in Sheehan Disability Scale (SDS) Total Score [ Time Frame: From Baseline to Week 8 ]The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)
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): NCT01034462
|Study Director:||Carl Gommoll, MS||Forest Research Institute, a subsidiary of Forest Laboratories Inc.|