At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 568 enrolled
Drug / intervention
Levomilnacipran ER +2 moredrug
Likely dose
Levomilnacipran ER 40mgfrom 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 Double-blind, Placebo-Controlled, Fixed-Dose Study of Levomilnacipran SR in Patients With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Levomilnacipran ER and Placebo for Major Depressive Disorder. Completed, enrolled 568 participants across 51 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER compared to placebo in patients with Major Depressive Disorder (MDD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2011
First PostedJun 2011
Primary CompletionMar 2012
TodayJul 2026
First PostedJun 21, 2011
Enrollment StartJun 1, 2011
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.0 years ago
Interventions
Levomilnacipran ERdrug
Drug: Levomilnacipran ER 40mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks
Levomilnacipran ERdrug
Drug: Levomilnacipran ER 80mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks
Placebodrug
Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.