Phase 3 N=734 Randomized Triple-blind Treatment

Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder

Depression · Major Depressive Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01085812 ↗

Enrolled (actual)

734

Serious AEs

1.2%

Results posted

Jan 2020

Primary outcome: Primary: Time to Relapse (Days) — NA; NA Days

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Levomilnacipran ER (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Forest Laboratories
Primary completion: Oct 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Relapse (Days)	NA; NA	—

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).

Eligibility Criteria

Inclusion Criteria

Men and women, 18-65 years old
Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
The patient's current depressive episode must be at least 4 weeks in duration

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
Patients with a history of meeting DSM-IV-TR criteria for:
any manic or hypomanic episode
schizophrenia or any other psychotic disorder
obsessive-compulsive disorder
Patients who are considered a suicide risk

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01085812). 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.