Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive disorder
Major Depressive Disorder
Drug: Levomilnacipran ER
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-blind, Placebo-Controlled, Flexible-Dose Study of F2695 SR in Patients With Major Depressive Disorder|
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: From Baseline to Week 8 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]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)
|Study Start Date:||December 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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.
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|Study Director:||Carl Gommoll, MS||Forest Research Institute, a subsidiary of Forest Laboratories Inc.|