CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 262 enrolled
Drug / intervention
Levomilnacipran ER +2 moredrug
Likely dose
Levomilnacipran ER 120 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01254305
NCT01254305Phase 2Completed
CompareCT.gov

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

Forest Laboratories·interventional·Posted Dec 6, 2010·Updated Aug 6, 2014

In Brief

A Phase 2 clinical trial evaluating Levomilnacipran ER, Paroxetine, Sertraline, Citalopram or Fluoxetine., and 1 other intervention for Major Depressive Disorder. Completed, enrolled 262 participants across 20 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 6, 2010
Enrollment StartApr 1, 2011
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.6 years ago

Interventions

Levomilnacipran ERdrug

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.drug

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

Placebodrug

Matching placebo capsules, oral administration, once daily dosing