Phase 4
N=644
A Multicenter, Relapse Prevention Study With Levomilnacipran Extended Release (ER) in Participants With Major Depressive Disorder
Depressive Disorder, Major
Bottom Line
View on ClinicalTrials.gov: NCT02288325 ↗Enrolled (actual)
644
Serious AEs
1.2%
Results posted
Oct 2018
Primary outcome: Primary: Time to First Relapse During the Double-Blind Treatment Period (DBTP) — NA; NA days — p=0.0212
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Levomilnacipran ER (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Forest Laboratories
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Relapse During the Double-Blind Treatment Period (DBTP) |
NA; NA | 0.0212 sig |
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).
Eligibility Criteria
Inclusion Criteria
- Currently meet the DMS-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) criteria for Major Depressive Disorder (MDD)
- The participant must have an ongoing major depressive episode of at least 8 weeks and no more than 18 months
- The participant must have at least 3 lifetime episodes of MDD (including the current episode)
Exclusion Criteria
- Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control
- Participants who are considered a suicide risk
- History of non-response to 2 or more antidepressants (after adequate treatment)
- Participants who have a history of meeting DMS-5 criteria for manic, hypomanic, or mixed episode, obsessive-compulsive disorder, schizophrenia or other psychotic disorder
- Panic disorder
Data sourced from ClinicalTrials.gov (NCT02288325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.