Clinical trial NCT01085812: Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder
Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Major Depressive Disorder
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2010-03-12
Enrollment: 734
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 safety and efficacy of Levomilnacipran ER relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).

Detailed description: Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with Levomilnacipran ER are randomized to continue Levomilnacipran ER or switch to placebo under double-blind conditions for up to 24 weeks of additional treatment.

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 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: Time to Relapse (Days)
timeFrame: 24 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Forest Investigative Site #023
state: California
city: Encino
country: United States
facility: Forest Investigative Site #017
state: California
city: Garden Grove
country: United States
facility: Forest Investigative Site #021
state: California
city: Newport Beach
country: United States
facility: Forest Investigative Site #025
state: California
city: Orange
country: United States
facility: Forest Investigative Site #030
state: California
city: San Diego
country: United States
facility: Forest Investigative Site #002
state: California
city: Sherman Oaks
country: United States
facility: Forest Investigative Site #003
state: California
city: Bonita Springs
country: United States
facility: Forest Research Institute #001
state: Florida
city: Fort Myers
country: United States
facility: Forest Investigative Site #015
state: Florida
city: Maitland
country: United States
facility: Forest Investigative Site #029
state: Florida
city: North Miami
country: United States
facility: Forest Investigative Site #005
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site #016
state: Florida
city: South Miami
country: United States
facility: Forest Investigative Site #004
state: Florida
city: Atlanta
country: United States
facility: Forest Investigative Site #014
state: Georgia
city: Chicago
country: United States
facility: Forest Investigative Site #022
state: Illinois
city: Chicago
country: United States
facility: Forest Investigative Site #006
state: Illinois
city: Prairie Village
country: United States
facility: Forest Investigative Site #009
state: Kansas
city: Baltimore
country: United States
facility: Forest Investigative Site #013
state: Maryland
city: Boston
country: United States
facility: Forest Investigative Site #010
state: Massachusetts
city: Saint Louis
country: United States
facility: Forest Investigative Site #012
state: Missouri
city: Staten Island
country: United States
facility: Forest Investigative Site #011
state: New York
city: Portland
country: United States
facility: Forest Investigative Site #026
state: Oregon
city: Bridgeville
country: United States
facility: Forest Investigative Site #008
state: Pennsylvania
city: Norristown
country: United States
facility: Forest Investigative Site #028
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site #020
state: Pennsylvania
city: Memphis
country: United States
facility: Forest Investigative Site #024
state: Tennessee
city: Dallas
country: United States
facility: Forest Investigative Site #007
state: Texas
city: San Antonio
country: United States
facility: Forest Investigative Site #019
state: Texas
city: Bellevue
country: United States
facility: Forest Investigative Site #018
state: Washington
city: Seattle
country: United States
facility: Forest Investigative Site #027
state: Washington
city: Kelowna
country: Canada
facility: Forest Investigative Site #050
state: British Columbia
city: Vancouver
country: Canada
facility: Forest Investigative Site #051
state: British Columbia
city: Sydney
country: Canada
facility: Forest Investigative Site #052
state: Nova Scotia
city: Chatham
country: Canada
facility: Forest Investigative Site #055
state: Ontario
city: Ottawa
country: Canada
facility: Forest Investigative Site #053
state: Ontario
Study officials:
affiliation: Forest Laboratories
name: Giovanna Forero, MA
role: STUDY_DIRECTOR
References: