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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: NCT01034462
Recruitment Status : Completed
First Posted : December 17, 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 : 442 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, 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 : December 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing.
Drug: Levomilnacipran ER
Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing. Study drug is to be given orally, in capsule form, once daily, for 8 weeks

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.

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: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. 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): NCT01034462

  Hide Study Locations
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United States, Alabama
Forest Investigative Site 055
Dothan, Alabama, United States, 36305
United States, Colorado
Forest Investigative Site 065
Highlands Ranch, Colorado, United States, 80130
United States, Florida
Forest Investigative Site 057
Boca Raton, Florida, United States, 33431
Forest Investigative Site 060
Boca Raton, Florida, United States, 33432
Forest Investigative Site 064
Gainesville, Florida, United States, 32607
Forest Investigative Site 053
Ocala, Florida, United States, 34471
Forest Investigative Site 061
Orlando, Florida, United States, 32806
Forest Investigative Site 059
Winter Park, Florida, United States, 32789
United States, Georgia
Forest Investigative Site 070
Atlanta, Georgia, United States, 30328
Forest Investigative Site 066
Smyrna, Georgia, United States, 30080
United States, Illinois
Forest Investigative Site 072
Chicago, Illinois, United States, 60634
Forest Investigative Site 050
Oakbrook, Illinois, United States, 60523
United States, Indiana
Forest Investigative Site 063
Indianapolis, Indiana, United States, 46260
United States, Kansas
Forest Investigative Site 071
Prairie Village, Kansas, United States, 66206
United States, Louisiana
Forest Investigative Site 052
Shreveport, Louisiana, United States, 71104
United States, New York
Forest Investigative Site 051
Brooklyn, New York, United States, 11214
United States, Oklahoma
Forest Investigative Site 056
Oklahoma City, Oklahoma, United States, 73112
Forest Investigative Site 067
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Forest Investigative Site 058
Salem, Oregon, United States, 97301
United States, Pennsylvania
Forest Investigative Site 054
Allentown, Pennsylvania, United States, 18104
United States, Texas
Forest Investigative Site 062
San Antonio, Texas, United States, 78229
United States, Virginia
Forest Investigative Site 068
Virginia Beach, Virginia, United States, 23452
United States, Washington
Forest Investigative Site 069
Spokane, Washington, United States, 99204
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: NCT01034462     History of Changes
Other Study ID Numbers: LVM-MD-03
First Posted: December 17, 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