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Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With 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: NCT01085812
Recruitment Status : Completed
First Posted : March 12, 2010
Results First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of Levomilnacipran ER relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).

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

Detailed Description:
Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with Levomilnacipran ER are randomized to continue Levomilnacipran ER or switch to placebo under double-blind conditions for up to 24 weeks of additional treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 734 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder
Study Start Date : March 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 2
40, 80 or 120 mg/day Levomilnacipran ER capsules, oral administration, once daily dosing.
Drug: Levomilnacipran ER
Drug: Levomilnacipran ER (40, 80 or 120 mg/day) Study drug is to be given orally, in capsule form, once daily.

Placebo Comparator: 1
Matching placebo capsules, oral administration, once daily dosing.
Drug: Placebo
Matching placebo to be given orally, in capsule form, once daily.




Primary Outcome Measures :
  1. Time to Relapse (Days) [ Time Frame: 24 Weeks ]
    Number of days until patients meet relapse criteria. Relapse was defined as 1 or more of the following: 1. MADRS total score of at least 22 at 2 consecutive visits 2. Increase of 2 or more points in CGI-I score compared with the CGI-I score at Visit 9 at 2 consecutive visits 3. Premature discontinuation due to insufficient therapeutic response 4. MADRS item 10 score of at least 4



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, 18-65 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 ClinicalTrials.gov identifier (NCT number): NCT01085812


Locations
Show Show 35 study locations
Sponsors and Collaborators
Forest Laboratories
Investigators
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Study Director: Giovanna Forero, MA Forest Laboratories
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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01085812    
Other Study ID Numbers: LVM-MD-05
First Posted: March 12, 2010    Key Record Dates
Results First Posted: January 13, 2020
Last Update Posted: January 13, 2020
Last Verified: December 2019
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
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