CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 724 enrolled
Drug / intervention
Levomilnacipran ER +3 moredrug
Likely dose
Levomilnacipran ER 40 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/NCT00969709
NCT00969709Phase 3Completed
CompareCT.gov

A Double-blind, Placebo-Controlled, Fixed-Dose Study of F2695 SR in Patients With Major Depressive Disorder

Forest Laboratories·interventional·Posted Sep 1, 2009·Updated Oct 25, 2013

In Brief

A Phase 3 clinical trial evaluating Levomilnacipran ER and Placebo for Major Depressive Disorder. Completed, enrolled 724 participants across 38 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER fixed doses versus placebo in the treatment of outpatients with major depressive disorder.

Study Details

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

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 1, 2009
Enrollment StartSep 1, 2009
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.8 years ago

Interventions

Levomilnacipran ERdrug

Levomilnacipran ER, 40 mg, oral administration, in capsule form, once daily for 8 weeks.

Levomilnacipran ERdrug

Levomilnacipran ER, 80 mg, oral administration, in capsule form, once daily for 8 weeks.

Levomilnacipran ERdrug

Levomilnacipran ER, 120 mg, oral administration, in capsule form, once daily for 8 weeks.

Placebodrug

Matching placebo capsules, oral administration, once daily for 8 weeks.