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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00969150
Recruitment Status : Completed
First Posted : September 1, 2009
Results First Posted : October 25, 2013
Last Update Posted : October 25, 2013
Information provided by (Responsible Party):
Forest Laboratories

Brief 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Levomilnacipran ER Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 362 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-Controlled, Flexible-Dose Study of F2695 SR in Patients With Major Depressive Disorder
Study Start Date : September 2009
Actual Primary Completion Date : November 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: 2
Matching placebo capsules, oral administration, once daily dosing.
Drug: Placebo
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
Drug: Levomilnacipran ER (flexible dose) Study drug is to be given orally, in capsule form, once daily, for 8 weeks.

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00969150

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United States, Arizona
Forest Investigative Site
Scottsdale, Arizona, United States, 85254
United States, California
Forest Investigative Site
Encino, California, United States, 91316
Forest Investigative Site
Los Alamitos, California, United States, 90720
Forest Investigative Site
Oceanside, California, United States, 92056
United States, Colorado
Forest Investigative Site
Denver, Colorado, United States, 80204
Forest Investigative Site
Denver, Colorado, United States, 80239
United States, Florida
Forest Investigative Site
Jacksonville, Florida, United States, 32216
Forest Investigative Site
Orlando, Florida, United States, 32806
United States, Illinois
Forest Investigative Site
Chicago, Illinois, United States, 60634
United States, Kansas
Forest Investigative Site
Wichita, Kansas, United States, 67206
United States, Maryland
Forest Investigative Site
Glen Burnie, Maryland, United States, 21061
United States, Massachusetts
Forest Investigative Site
Fall River, Massachusetts, United States, 02721
United States, Michigan
Forest Investigative Site
East Lansing, Michigan, United States, 48824
United States, New Jersey
Forest Investigative Site
Cherry Hill, New Jersey, United States, 08002
United States, New York
Forest Investigative Site
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
United States, Ohio
Forest Investigative Site 013
Canton, Ohio, United States, 44718
Forest Investigative Site
Dayton, Ohio, United States, 45417
United States, Oregon
Forest Investigative Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
Forest Investigative Site
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Forest Investigative Site
Lincoln, Rhode Island, United States, 02865
United States, Vermont
Forest Investigative Site
Woodstock, Vermont, United States, 05091
United States, Washington
Forest Investigative Site
Bellevue, Washington, United States, 98007
Forest Investigative Site
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Forest Laboratories
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Study Director: Carl Gommoll, MS Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Forest Laboratories Identifier: NCT00969150    
Other Study ID Numbers: LVM-MD-02
First Posted: September 1, 2009    Key Record Dates
Results First Posted: October 25, 2013
Last Update Posted: October 25, 2013
Last Verified: August 2013
Keywords provided by Forest Laboratories:
Major Depressive Disorder
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents