NCT01254305 - Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder | Biotech Hunter

Enrollment

262

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

July 31, 2012

Study Completion Date

July 31, 2012

Conditions

Major Depressive Disorder

Interventions

DRUG

Levomilnacipran ER

Drug: Levomilnacipran ER (40 -120 mg/day) Study drug is to be given orally, in capsule form, once daily for 8 weeks

DRUG

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

DRUG

Placebo

Matching placebo capsules, oral administration, once daily dosing

Trial Locations (20)

10467

Forest Investigative Site 011, The Bronx

11516

Forest Investigative Site 015, Cedarhurst

30308

Forest Investigative Site 009, Atlanta

32216

Forest Investigative Site 006, Jacksonville

32763

Forest Investigative Site 017, Orange City

32806

Forest Investigative Site 005, Orlando

33613

Forest Investigative Site 012, Tampa

33912

Forest Investigative Site 014, Fort Myers

35216

Forest Investigative Site 010, Birmingham

38119

Forest Investigative Site 018, Memphis

45227

Forest Investigative Site 003, Cincinnati

45417

Forest Investigative Site 013, Dayton

53562

Forest Investigative Site 007, Middleton

60435

Forest Investigative Site 016, Joliet

70122

Forest Investigative Site 004, New Orleans

72223

Forest Investigative Site 002, Little Rock

75235

Forest Investigative Site 008, Dallas

90703

Forest Investigative Site 001, Cerritos

02135

Forest Investigative Site 022, Boston

02865

Forest Investigative Site 020, Lincoln