Clinical trial NCT00969150: Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
Official title: A Double-blind, Placebo-Controlled, Flexible-Dose Study of F2695 SR in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Depression
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2009-09-01
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 versus placebo in the treatment of outpatients with major depressive disorder.


Eligibility criteria: Inclusion Criteria:

* Men and women, 18-80 years old
* Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
* The patient's current depressive episode must be at least 4 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-Asberg 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: Scottsdale
country: United States
facility: Forest Investigative Site
state: Arizona
city: Encino
country: United States
facility: Forest Investigative Site
state: California
city: Los Alamitos
country: United States
facility: Forest Investigative Site
state: California
city: Oceanside
country: United States
facility: Forest Investigative Site
state: California
city: Denver
country: United States
facility: Forest Investigative Site
state: Colorado
city: Denver
country: United States
facility: Forest Investigative Site
state: Colorado
city: Jacksonville
country: United States
facility: Forest Investigative Site
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site
state: Florida
city: Chicago
country: United States
facility: Forest Investigative Site
state: Illinois
city: Wichita
country: United States
facility: Forest Investigative Site
state: Kansas
city: Glen Burnie
country: United States
facility: Forest Investigative Site
state: Maryland
city: Fall River
country: United States
facility: Forest Investigative Site
state: Massachusetts
city: East Lansing
country: United States
facility: Forest Investigative Site
state: Michigan
city: Cherry Hill
country: United States
facility: Forest Investigative Site
state: New Jersey
city: Brooklyn
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: Canton
country: United States
facility: Forest Investigative Site 013
state: Ohio
city: Dayton
country: United States
facility: Forest Investigative Site
state: Ohio
city: Portland
country: United States
facility: Forest Investigative Site
state: Oregon
city: Philadelphia
country: United States
facility: Forest Investigative Site
state: Pennsylvania
city: Lincoln
country: United States
facility: Forest Investigative Site
state: Rhode Island
city: Woodstock
country: United States
facility: Forest Investigative Site
state: Vermont
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: Gommoll CP, Greenberg WM, Chen C. A randomized, double-blind, placebo-controlled study of flexible doses of levomilnacipran ER (40-120 mg/day) in patients with major depressive disorder. J Drug Assess. 2014 Jan 16;3(1):10-9. doi: 10.3109/21556660.2014.884505. eCollection 2014.