Clinical trial NCT00969709: Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
Official title: A Double-blind, Placebo-Controlled, Fixed-Dose Study of F2695 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: 2009-09-01
Enrollment: 724
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 fixed doses versus placebo in the treatment of outpatients with major depressive disorder.


Eligibility criteria: Inclusion Criteria:

* Men and women, 18-65 years old
* Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
* The patient's current depressive episode must be at least 8 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 with a history of meeting DSM-IV-TR criteria for:

  * any manic or hypomanic episode
  * schizophrenia or any other psychotic disorder
  * obsessive-compulsive disorder
* Patients who are considered a suicide risk

Primary outcomes:
measure: Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
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: Phoenix
country: United States
facility: Forest Investigative Site
state: Arizona
city: Scottsdale
country: United States
facility: Forest Investigative Site
state: Arizona
city: Beverly Hills
country: United States
facility: Forest Investigative Site
state: California
city: Costa Mesa
country: United States
facility: Forest Investigative Site
state: California
city: Escondido
country: United States
facility: Forest Investigative Site
state: California
city: Oceanside
country: United States
facility: Forest Investigative Site
state: California
city: Sherman Oaks
country: United States
facility: Forest Investigative Site
state: California
city: Denver
country: United States
facility: Forest Investigative Site
state: Colorado
city: Cromwell
country: United States
facility: Forest Investigative Site
state: Connecticut
city: Coral Springs
country: United States
facility: Forest Investigative Site
state: Florida
city: Fort Myers
country: United States
facility: Forest Investigative Site
state: Florida
city: Hallandale Beach
country: United States
facility: Forest Investigative Site
state: Florida
city: Jacksonville
country: United States
facility: Forest Investigative Site
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site
state: Florida
city: West Palm Beach
country: United States
facility: Forest Investigative Site
state: Florida
city: Hoffman Estates
country: United States
facility: Forest Investigative Site
state: Illinois
city: Wichita
country: United States
facility: Forest Investigative Site
state: Kansas
city: Baltimore
country: United States
facility: Forest Investigative Site
state: Maryland
city: Rockville
country: United States
facility: Forest Investigative Site
state: Maryland
city: Cherry Hill
country: United States
facility: Forest Investigative Site
state: New Jersey
city: Willingboro
country: United States
facility: Forest Investigative Site
state: New Jersey
city: Brooklyn
country: United States
facility: Forest Investigative Site
state: New York
city: Mt. Kisco
country: United States
facility: Forest Investigative Site
state: New York
city: New York
country: United States
facility: Forest Investigative Site
state: New York
city: New York
country: United States
facility: Forest Investigative Site
state: New York
city: Staten Island
country: United States
facility: Forest Investigative Site
state: New York
city: Raleigh
country: United States
facility: Forest Investigative Site
state: North Carolina
city: Canton
country: United States
facility: Forest Investigative Site
state: Ohio
city: Portland
country: United States
facility: Forest Investigative Site
state: Oregon
city: Media
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: Norristown
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: Lincoln
country: United States
facility: Forest Investigative Site
state: Rhode Island
city: Memphis
country: United States
facility: Forest Investigative Site
state: Tennessee
city: Dallas
country: United States
facility: Forest Investigative Site
state: Texas
city: Dallas
country: United States
facility: Forest Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site
state: Texas
city: Bellevue
country: United States
facility: Forest Investigative Site
state: Washington
city: Seattle
country: United States
facility: Forest Investigative Site
state: Washington
Study officials:
affiliation: Forest Research Institute, a subsidiary of Forest Laboratories Inc.
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: Blum SI, Tourkodimitris S, Ruth A. Evaluation of functional health and well-being in patients receiving levomilnacipran ER for the treatment of major depressive disorder. J Affect Disord. 2015 Jan 1;170:230-6. doi: 10.1016/j.jad.2014.09.005. Epub 2014 Sep 10.
citation: Asnis GM, Bose A, Gommoll CP, Chen C, Greenberg WM. Efficacy and safety of levomilnacipran sustained release 40 mg, 80 mg, or 120 mg in major depressive disorder: a phase 3, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2013 Mar;74(3):242-8. doi: 10.4088/JCP.12m08197.