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Safety and Efficacy of Levomilnacipran ER (Levomilnacipran 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.
 
ClinicalTrials.gov Identifier: NCT01377194
Recruitment Status : Completed
First Posted : June 21, 2011
Results First Posted : October 29, 2013
Last Update Posted : October 29, 2013
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Study Description
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Brief 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).

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 568 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-Controlled, Fixed-Dose Study of Levomilnacipran SR in Patients With Major Depressive Disorder
Study Start Date : June 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
40mg Levomilnacipran ER
 Drug: Levomilnacipran ER
Drug: Levomilnacipran ER 40mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks
Experimental: 2
80mg of Levomilnacipran ER
 Drug: Levomilnacipran ER
Drug: Levomilnacipran ER 80mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks
Placebo Comparator: 3
Placebo
 Drug: Placebo
Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis. [ Time Frame: From Baseline to Week 8 ]
    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).


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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01377194


Locations
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Sponsors and Collaborators
Forest Laboratories
Investigators
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Study Director: Carl Gommoll, MS Forest Research Institute, a subsidiary of Forest Laboratories
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01377194    
Other Study ID Numbers: LVM-MD-10
First Posted: June 21, 2011    Key Record Dates
Results First Posted: October 29, 2013
Last Update Posted: October 29, 2013
Last Verified: August 2013
Keywords provided by Forest Laboratories:
Depression
Major Depressive Disorder
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Milnacipran
Levomilnacipran
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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents