Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder

Depression Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085812
• Other study ID #: LVM-MD-05
• Status: Completed
• Phase: Phase 3
• Start date: March 2010
• Est. completion date: October 2011

Study information

• Verified date: December 2019
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 734
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Levomilnacipran ER
Drug: Levomilnacipran ER (40, 80 or 120 mg/day) Study drug is to be given orally, in capsule form, once daily.
• Placebo
Matching placebo to be given orally, in capsule form, once daily.

Locations

Country	Name	City	State
Canada	Forest Investigative Site #055	Chatham	Ontario
Canada	Forest Investigative Site #050	Kelowna	British Columbia
Canada	Forest Investigative Site #053	Ottawa	Ontario
Canada	Forest Investigative Site #052	Sydney	Nova Scotia
Canada	Forest Investigative Site #051	Vancouver	British Columbia
United States	Forest Investigative Site #014	Atlanta	Georgia
United States	Forest Investigative Site #013	Baltimore	Maryland
United States	Forest Investigative Site #018	Bellevue	Washington
United States	Forest Investigative Site #023	Beverly Hills	California
United States	Forest Research Institute #001	Bonita Springs	Florida
United States	Forest Investigative Site #010	Boston	Massachusetts
United States	Forest Investigative Site #008	Bridgeville	Pennsylvania
United States	Forest Investigative Site #006	Chicago	Illinois
United States	Forest Investigative Site #022	Chicago	Illinois
United States	Forest Investigative Site #007	Dallas	Texas
United States	Forest Investigative Site #017	Encino	California
United States	Forest Investigative Site #015	Fort Myers	Florida
United States	Forest Investigative Site #021	Garden Grove	California
United States	Forest Investigative Site #029	Maitland	Florida
United States	Forest Investigative Site #024	Memphis	Tennessee
United States	Forest Investigative Site #025	Newport Beach	California
United States	Forest Investigative Site #028	Norristown	Pennsylvania
United States	Forest Investigative Site #005	North Miami	Florida
United States	Forest Investigative Site #030	Orange	California
United States	Forest Investigative Site #016	Orlando	Florida
United States	Forest Investigative Site #020	Philadelphia	Pennsylvania
United States	Forest Investigative Site #026	Portland	Oregon
United States	Forest Investigative Site #009	Prairie Village	Kansas
United States	Forest Investigative Site #012	Saint Louis	Missouri
United States	Forest Investigative Site #019	San Antonio	Texas
United States	Forest Investigative Site #002	San Diego	California
United States	Forest Investigative Site #027	Seattle	Washington
United States	Forest Investigative Site #003	Sherman Oaks	California
United States	Forest Investigative Site #004	South Miami	Florida
United States	Forest Investigative Site #011	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Relapse (Days)	Number of days until patients meet relapse criteria. Relapse was defined as 1 or more of the following: 1. MADRS total score of at least 22 at 2 consecutive visits 2. Increase of 2 or more points in CGI-I score compared with the CGI-I score at Visit 9 at 2 consecutive visits 3. Premature discontinuation due to insufficient therapeutic response 4. MADRS item 10 score of at least 4	24 Weeks