At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 734 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 F2695 SR in Patients With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Levomilnacipran ER and Placebo for Depression and Major Depressive Disorder. Completed, enrolled 734 participants across 35 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of Levomilnacipran ER relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, Major Depressive Disorder
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2010
First PostedMar 2010
Primary CompletionOct 2011
TodayJul 2026
First PostedMar 12, 2010
Enrollment StartMar 1, 2010
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.3 years ago
Interventions
Levomilnacipran ERdrug
Drug: Levomilnacipran ER (40, 80 or 120 mg/day) Study drug is to be given orally, in capsule form, once daily.
Placebodrug
Matching placebo to be given orally, in capsule form, once daily.