Safety and Efficacy of Levomilnacipran ER (Levomilnacipran SR) in Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

A Double-blind, Placebo-Controlled, Fixed-Dose Study of Levomilnacipran SR in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01377194
• Other study ID #: LVM-MD-10
• Status: Completed
• Phase: Phase 3
• First received: June 10, 2011
• Last updated: August 22, 2013
• Start date: June 2011
• Est. completion date: March 2012

Study information

• Verified date: August 2013
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 568
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Levomilnacipran ER
Drug: Levomilnacipran ER 40mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks
• Levomilnacipran ER
Drug: Levomilnacipran ER 80mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks
• Placebo
Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.

Locations

Country	Name	City	State
Canada	Forest Investigative Site 006	Chatham	Ontario
Canada	Forest Investigative Site 025	Kelowna	British Columbia
Canada	Forest Investigative Site 003	Ottawa	Ontario
Canada	Forest Investigative Site 036	Sydney	Nova Scotia
United States	Forest Investigative Site 011	Allentown	Pennsylvania
United States	Forest Investigative Site 046	Atlanta	Georgia
United States	Forest Investigative Site 022	Bellevue	Washington
United States	Forest Investigative Site 037	Beverly Hills	California
United States	Forest Investigative Site 039	Birmingham	Alabama
United States	Forest Investigative Site 052	Bridgeville	Pennsylvania
United States	Forest Investigative Site 004	Brooklyn	New York
United States	Forest Investigative Site 044	Cherry Hill	New Jersey
United States	Forest Investigative Site 041	Chicago	Illinois
United States	Forest Investigative Site 054	Chicago	Illinois
United States	Forest Investigative Site 021	Coral Springs	Florida
United States	Forest Investigative Site 034	Cromwell	Connecticut
United States	Forest Investigative Site 009	Dallas	Texas
United States	Forest Investigative Site 010	Dayton	Ohio
United States	Forest Investigative Site 012	Encino	California
United States	Forest Investigative Site 043	Fort Myers	Florida
United States	Forest Investigative Site 018	Gainesville	Florida
United States	Forest Investigative Site 060	Hallandale Beach	Florida
United States	Forest Investigative Site 049	Haverhill	Massachusetts
United States	Forest Investigative Site 026	Hoffman Estates	Illinois
United States	Forest Investigative Site 045	Indianapolis	Indiana
United States	Forest Investigative Site 020	Jacksonville	Florida
United States	Forest Investigative Site 059	Lincoln	Rhode Island
United States	Forest Investigative Site 029	Memphis	Tennessee
United States	Forest Investigative Site 002	Mount Kisco	New York
United States	Forest Investigative Site 051	New York	New York
United States	Forest Investigative Site 016	New York City	New York
United States	Forest Investigative Site 038	Newport Beach	California
United States	Forest Investigative Site 005	Ocala	Florida
United States	Forest Investigative Site 024	Oceanside	California
United States	Forest Investigative Site 048	Oklahoma City	Oklahoma
United States	Forest Investigative Site 042	Orangeburg	New York
United States	Forest Investigative Site 014	Orlando	Florida
United States	Forest Investigative Site 028	Orlando	Florida
United States	Forest Investigative Site 027	Philadelphia	Pennsylvania
United States	Forest Investigative Site 053	Portland	Oregon
United States	Forest Investigative Site 056	Prairie Village	Kansas
United States	Forest Investigative Site 061	Raleigh	North Carolina
United States	Forest Investigative Site 001	Redlands	California
United States	Forest Investigative Site 017	Salem	Oregon
United States	Forest Investigative Site 007	San Antonio	Texas
United States	Forest Investigative Site 035	San Antonio	Texas
United States	Forest Investigative Site 031	San Diego	California
United States	Forest Investigative Site 055	Seattle	Washington
United States	Forest Investigative Site 050	Sherman Oaks	California
United States	Forest Investigative Site 057	Spokane	Washington
United States	Forest Investigative Site 023	Willingboro	New Jersey

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	Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis.	The Montgomery-Asberg Depression Rating Scale (MADRS) rates patients on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale. A score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The minimum overall score possible was 0 (absence of symptoms), with a maximum overall score of 60 (maximum severity).	From Baseline to Week 8	No
Secondary	Change in Sheehan Disability Scale (SDS) Total Score	The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)	From Baseline to Week 8	No