At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 644 enrolled
Drug / intervention
Levomilnacipran ER +1 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.
A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With Levomilnacipran ER in Patients With Major Depressive Disorder
In Brief
A Phase 4 clinical trial evaluating Levomilnacipran ER and Placebo for Depressive Disorder, Major. Completed, enrolled 644 participants across 47 sites.
Detailed Summary
This study evaluates the efficacy, safety and tolerability of levomilnacipran extended-release (ER) compared with placebo in the prevention of depression relapse in major depressive disorder (MDD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder, Major
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 2014
Enrollment StartNov 2014
Primary CompletionSep 2016
TodayJul 2026
First PostedNov 11, 2014
Enrollment StartNov 18, 2014
Primary CompletionSep 16, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.6 years ago
Interventions
Levomilnacipran ERdrug
Levomilnacipran ER taken orally at 40, 80 or 120 mg once daily.
Placebodrug
Dose-matched placebo taken orally once daily.