NCT01254305

Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder

A Double-blind, Randomized, Placebo- and Active-Controlled Study of F2695 SR in Adult Patients With Fatigue Associated With Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy, safety and tolerability of Levomilnacipran ER for the treatment of fatigue associated with major depressive disorder (MDD).

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2010-12-06
• Last updated: 2014-08-06
• Results posted: 2014-08-06

Locations

20 sites across 1 country: United States