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

August 22, 2013 updated by: Forest Laboratories

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

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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

362

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Scottsdale, Arizona, United States, 85254
        • Forest Investigative Site
    • California
      • Encino, California, United States, 91316
        • Forest Investigative Site
      • Los Alamitos, California, United States, 90720
        • Forest Investigative Site
      • Oceanside, California, United States, 92056
        • Forest Investigative Site
    • Colorado
      • Denver, Colorado, United States, 80239
        • Forest Investigative Site
      • Denver, Colorado, United States, 80204
        • Forest Investigative Site
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Forest Investigative Site
      • Orlando, Florida, United States, 32806
        • Forest Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Forest Investigative Site
    • Kansas
      • Wichita, Kansas, United States, 67206
        • Forest Investigative Site
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
        • Forest Investigative Site
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • Forest Investigative Site
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Forest Investigative Site
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Forest Investigative Site
    • New York
      • Brooklyn, New York, United States, 11235
        • Forest Investigative Site
      • New York, New York, United States, 10021
        • Forest Investigative Site
      • Staten Island, New York, United States, 10312
        • Forest Investigative Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Forest Investigative Site 013
      • Dayton, Ohio, United States, 45417
        • Forest Investigative Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Forest Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Forest Investigative Site
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Forest Investigative Site
    • Vermont
      • Woodstock, Vermont, United States, 05091
        • Forest Investigative Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Forest Investigative Site
      • Seattle, Washington, United States, 98104
        • Forest Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Matching placebo capsules, oral administration, once daily dosing.
Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.
EXPERIMENTAL: 1
Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing.
Drug: Levomilnacipran ER (flexible dose) Study drug is to be given orally, in capsule form, once daily, for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time Frame: From Baseline to Week 8

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sheehan Disability Scale (SDS) Total Score
Time Frame: From Baseline to Week 8
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Carl Gommoll, MS, Forest Research Institute, a Subsidiary of Forest Laboratories, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

August 31, 2009

First Submitted That Met QC Criteria

August 31, 2009

First Posted (ESTIMATE)

September 1, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 25, 2013

Last Update Submitted That Met QC Criteria

August 22, 2013

Last Verified

August 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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