Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
NCT ID: NCT00969150
Last Updated: 2013-10-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
362 participants
INTERVENTIONAL
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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2
Matching placebo capsules, oral administration, once daily dosing.
Placebo
Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.
1
Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing.
Levomilnacipran ER
Drug: Levomilnacipran ER (flexible dose) Study drug is to be given orally, in capsule form, once daily, for 8 weeks.
Interventions
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Levomilnacipran ER
Drug: Levomilnacipran ER (flexible dose) Study drug is to be given orally, in capsule form, once daily, for 8 weeks.
Placebo
Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Carl Gommoll, MS
Role: STUDY_DIRECTOR
Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Locations
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Forest Investigative Site
Scottsdale, Arizona, United States
Forest Investigative Site
Encino, California, United States
Forest Investigative Site
Los Alamitos, California, United States
Forest Investigative Site
Oceanside, California, United States
Forest Investigative Site
Denver, Colorado, United States
Forest Investigative Site
Denver, Colorado, United States
Forest Investigative Site
Jacksonville, Florida, United States
Forest Investigative Site
Orlando, Florida, United States
Forest Investigative Site
Chicago, Illinois, United States
Forest Investigative Site
Wichita, Kansas, United States
Forest Investigative Site
Glen Burnie, Maryland, United States
Forest Investigative Site
Fall River, Massachusetts, United States
Forest Investigative Site
East Lansing, Michigan, United States
Forest Investigative Site
Cherry Hill, New Jersey, United States
Forest Investigative Site
Brooklyn, New York, United States
Forest Investigative Site
New York, New York, United States
Forest Investigative Site
Staten Island, New York, United States
Forest Investigative Site 013
Canton, Ohio, United States
Forest Investigative Site
Dayton, Ohio, United States
Forest Investigative Site
Portland, Oregon, United States
Forest Investigative Site
Philadelphia, Pennsylvania, United States
Forest Investigative Site
Lincoln, Rhode Island, United States
Forest Investigative Site
Woodstock, Vermont, United States
Forest Investigative Site
Bellevue, Washington, United States
Forest Investigative Site
Seattle, Washington, United States
Countries
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References
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Gommoll CP, Greenberg WM, Chen C. A randomized, double-blind, placebo-controlled study of flexible doses of levomilnacipran ER (40-120 mg/day) in patients with major depressive disorder. J Drug Assess. 2014 Jan 16;3(1):10-9. doi: 10.3109/21556660.2014.884505. eCollection 2014.
Cutler AJ, Gommoll CP, Chen C, Greenberg WM, Ruth A. Levomilnacipran Extended-Release Treatment in Patients With Major Depressive Disorder: Improvements in Functional Impairment Categories. Prim Care Companion CNS Disord. 2015 Jun 11;17(3):10.4088/PCC.14m01753. doi: 10.4088/PCC.14m01753. eCollection 2015.
Other Identifiers
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LVM-MD-02
Identifier Type: -
Identifier Source: org_study_id