Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder
NCT ID: NCT01254305
Last Updated: 2014-08-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
262 participants
INTERVENTIONAL
2011-04-30
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
40 -120 mg/day Levomilnacipran ER capsules, oral administration
Levomilnacipran ER
Drug: Levomilnacipran ER (40 -120 mg/day) Study drug is to be given orally, in capsule form, once daily for 8 weeks
2
Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine Oral administration, once daily dosing
Paroxetine, Sertraline, Citalopram or Fluoxetine.
Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks
3
Matching placebo capsules, oral administration
Placebo
Matching placebo capsules, oral administration, once daily dosing
Interventions
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Levomilnacipran ER
Drug: Levomilnacipran ER (40 -120 mg/day) Study drug is to be given orally, in capsule form, once daily for 8 weeks
Paroxetine, Sertraline, Citalopram or Fluoxetine.
Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks
Placebo
Matching placebo capsules, oral administration, once daily dosing
Eligibility Criteria
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Inclusion Criteria
* Currently meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (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:
1. any manic or hypomanic episode;
2. schizophrenia or any other psychotic disorder;
3. obsessive-compulsive disorder.
* Patients who are considered a suicide risk
18 Years
65 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 Laboratories
Locations
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Forest Investigative Site 010
Birmingham, Alabama, United States
Forest Investigative Site 002
Little Rock, Arkansas, United States
Forest Investigative Site 001
Cerritos, California, United States
Forest Investigative Site 014
Fort Myers, Florida, United States
Forest Investigative Site 006
Jacksonville, Florida, United States
Forest Investigative Site 017
Orange City, Florida, United States
Forest Investigative Site 005
Orlando, Florida, United States
Forest Investigative Site 012
Tampa, Florida, United States
Forest Investigative Site 009
Atlanta, Georgia, United States
Forest Investigative Site 016
Joliet, Illinois, United States
Forest Investigative Site 004
New Orleans, Louisiana, United States
Forest Investigative Site 022
Boston, Massachusetts, United States
Forest Investigative Site 015
Cedarhurst, New York, United States
Forest Investigative Site 011
The Bronx, New York, United States
Forest Investigative Site 003
Cincinnati, Ohio, United States
Forest Investigative Site 013
Dayton, Ohio, United States
Forest Investigative Site 020
Lincoln, Rhode Island, United States
Forest Investigative Site 018
Memphis, Tennessee, United States
Forest Investigative Site 008
Dallas, Texas, United States
Forest Investigative Site 007
Middleton, Wisconsin, United States
Countries
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Other Identifiers
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LVM-MD-06
Identifier Type: -
Identifier Source: org_study_id
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