Clinical trial NCT01377194: Safety and Efficacy of Levomilnacipran ER (Levomilnacipran SR) in Major Depressive Disorder
Official title: A Double-blind, Placebo-Controlled, Fixed-Dose Study of Levomilnacipran SR in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Depression
Major Depressive Disorder
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2011-06-21
Enrollment: 568
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER compared to placebo in patients with Major Depressive Disorder (MDD).


Eligibility criteria: Inclusion Criteria:

* Men and women, 18-75 years old
* Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
* The patient's current depressive episode must be at least 6 weeks in duration

Exclusion Criteria:

* Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control.
* Patients who are considered a suicide risk
* Patients with a history of meeting DSM-IV-TR criteria for
* a. any manic or hypomanic episode
* b. schizophrenia or any other psychotic disorder
* c. obsessive-compulsive disorder.

Primary outcomes:
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis.
timeFrame: From Baseline to Week 8
Secondary outcomes:
measure: Change in Sheehan Disability Scale (SDS) Total Score
timeFrame: From Baseline to Week 8
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Forest Investigative Site 039
state: Alabama
city: Beverly Hills
country: United States
facility: Forest Investigative Site 037
state: California
city: Encino
country: United States
facility: Forest Investigative Site 012
state: California
city: Newport Beach
country: United States
facility: Forest Investigative Site 038
state: California
city: Oceanside
country: United States
facility: Forest Investigative Site 024
state: California
city: Redlands
country: United States
facility: Forest Investigative Site 001
state: California
city: San Diego
country: United States
facility: Forest Investigative Site 031
state: California
city: Sherman Oaks
country: United States
facility: Forest Investigative Site 050
state: California
city: Cromwell
country: United States
facility: Forest Investigative Site 034
state: Connecticut
city: Coral Springs
country: United States
facility: Forest Investigative Site 021
state: Florida
city: Fort Myers
country: United States
facility: Forest Investigative Site 043
state: Florida
city: Gainesville
country: United States
facility: Forest Investigative Site 018
state: Florida
city: Hallandale Beach
country: United States
facility: Forest Investigative Site 060
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site 020
state: Florida
city: Ocala
country: United States
facility: Forest Investigative Site 005
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 014
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 028
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site 046
state: Georgia
city: Chicago
country: United States
facility: Forest Investigative Site 041
state: Illinois
city: Chicago
country: United States
facility: Forest Investigative Site 054
state: Illinois
city: Hoffman Estates
country: United States
facility: Forest Investigative Site 026
state: Illinois
city: Indianapolis
country: United States
facility: Forest Investigative Site 045
state: Indiana
city: Prairie Village
country: United States
facility: Forest Investigative Site 056
state: Kansas
city: Haverhill
country: United States
facility: Forest Investigative Site 049
state: Massachusetts
city: Cherry Hill
country: United States
facility: Forest Investigative Site 044
state: New Jersey
city: Willingboro
country: United States
facility: Forest Investigative Site 023
state: New Jersey
city: Brooklyn
country: United States
facility: Forest Investigative Site 004
state: New York
city: Mount Kisco
country: United States
facility: Forest Investigative Site 002
state: New York
city: New York City
country: United States
facility: Forest Investigative Site 016
state: New York
city: New York
country: United States
facility: Forest Investigative Site 051
state: New York
city: Orangeburg
country: United States
facility: Forest Investigative Site 042
state: New York
city: Raleigh
country: United States
facility: Forest Investigative Site 061
state: North Carolina
city: Dayton
country: United States
facility: Forest Investigative Site 010
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site 048
state: Oklahoma
city: Portland
country: United States
facility: Forest Investigative Site 053
state: Oregon
city: Salem
country: United States
facility: Forest Investigative Site 017
state: Oregon
city: Allentown
country: United States
facility: Forest Investigative Site 011
state: Pennsylvania
city: Bridgeville
country: United States
facility: Forest Investigative Site 052
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site 027
state: Pennsylvania
city: Lincoln
country: United States
facility: Forest Investigative Site 059
state: Rhode Island
city: Memphis
country: United States
facility: Forest Investigative Site 029
state: Tennessee
city: Dallas
country: United States
facility: Forest Investigative Site 009
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 007
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site 035
state: Texas
city: Bellevue
country: United States
facility: Forest Investigative Site 022
state: Washington
city: Seattle
country: United States
facility: Forest Investigative Site 055
state: Washington
city: Spokane
country: United States
facility: Forest Investigative Site 057
state: Washington
city: Kelowna
country: Canada
facility: Forest Investigative Site 025
state: British Columbia
city: Sydney
country: Canada
facility: Forest Investigative Site 036
state: Nova Scotia
city: Chatham
country: Canada
facility: Forest Investigative Site 006
state: Ontario
city: Ottawa
country: Canada
facility: Forest Investigative Site 003
state: Ontario
Study officials:
affiliation: Forest Research Institute, a subsidiary of Forest Laboratories
name: Carl Gommoll, MS
role: STUDY_DIRECTOR
References:
citation: Cutler AJ, Gommoll CP, Chen C, Greenberg WM, Ruth A. Levomilnacipran Extended-Release Treatment in Patients With Major Depressive Disorder: Improvements in Functional Impairment Categories. Prim Care Companion CNS Disord. 2015 Jun 11;17(3):10.4088/PCC.14m01753. doi: 10.4088/PCC.14m01753. eCollection 2015.
citation: Bakish D, Bose A, Gommoll C, Chen C, Nunez R, Greenberg WM, Liebowitz M, Khan A. Levomilnacipran ER 40 mg and 80 mg in patients with major depressive disorder: a phase III, randomized, double-blind, fixed-dose, placebo-controlled study. J Psychiatry Neurosci. 2014 Jan;39(1):40-9. doi: 10.1503/jpn.130040.