At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 442 enrolled
Drug / intervention
Levomilnacipran ER +1 moredrug
Likely dose
Not stated in 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, Flexible-Dose Study of F2695 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 442 participants across 23 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER 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
Enrollment StartDec 2009
First PostedDec 2009
Primary CompletionDec 2011
TodayJul 2026
First PostedDec 17, 2009
Enrollment StartDec 1, 2009
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 16.5 years ago
Interventions
Levomilnacipran ERdrug
Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing. 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.