Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

A Double-blind, Placebo-Controlled, Flexible-Dose Study of F2695 SR in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00969150
• Other study ID #: LVM-MD-02
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2009
• Last updated: August 22, 2013
• Start date: September 2009

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, 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 (flexible dose) 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
United States	Forest Investigative Site	Bellevue	Washington
United States	Forest Investigative Site	Brooklyn	New York
United States	Forest Investigative Site 013	Canton	Ohio
United States	Forest Investigative Site	Cherry Hill	New Jersey
United States	Forest Investigative Site	Chicago	Illinois
United States	Forest Investigative Site	Dayton	Ohio
United States	Forest Investigative Site	Denver	Colorado
United States	Forest Investigative Site	Denver	Colorado
United States	Forest Investigative Site	East Lansing	Michigan
United States	Forest Investigative Site	Encino	California
United States	Forest Investigative Site	Fall River	Massachusetts
United States	Forest Investigative Site	Glen Burnie	Maryland
United States	Forest Investigative Site	Jacksonville	Florida
United States	Forest Investigative Site	Lincoln	Rhode Island
United States	Forest Investigative Site	Los Alamitos	California
United States	Forest Investigative Site	New York	New York
United States	Forest Investigative Site	Oceanside	California
United States	Forest Investigative Site	Orlando	Florida
United States	Forest Investigative Site	Philadelphia	Pennsylvania
United States	Forest Investigative Site	Portland	Oregon
United States	Forest Investigative Site	Scottsdale	Arizona
United States	Forest Investigative Site	Seattle	Washington
United States	Forest Investigative Site	Staten Island	New York
United States	Forest Investigative Site	Wichita	Kansas
United States	Forest Investigative Site	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	MADRS was used to assess depressive symptomatology during the past week. Patients are rated 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 of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms) to 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