Adults 18 to 70, any sex, with Depressive Disorder, Major. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time to First Relapse During the Double-Blind Treatment Period (DBTP)Primary· From the randomization date (Week 20) to the relapse date during the 26-week DBTP (up to Week 46)
Time to relapse for the median was measured in days from randomization date at the start of the DBTP to relapse date during DBTP. Relapse was defined as meeting any 1 or more of the following criteria: 1) Insufficient therapeutic response at any one visit, including a \>/= 2 increase in Clinical Global Impressions-Severity (CGI-S) score (range 1 to 7) compared with that obtained at randomization, or risk of suicide as determined by the investigator, or need for hospitalization due to worsening of depression as determined by the investigator, or need for alternative treatment of depressive symp
Group
Value
95% CI
Double-Blind Placebo
NA
NA – NA
Double-Blind FETZIMA®
NA
NA – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 48 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Open-Label FETZIMA®
Serious: 9/644 (1%)
Deaths: 0/644
Double-Blind Placebo
Serious: 1/159 (1%)
Deaths: 0/159
Double-Blind FETZIMA®
Serious: 2/165 (1%)
Deaths: 0/165
Serious adverse events (15 terms)
Reaction
System
Open-Label FETZIMA®
Double-Blind Placebo
Double-Blind FETZIMA®
Panic attack
Psychiatric disorders
—
—
—
Oesophageal squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03569475 — Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disord
· Phase 3
· completed
Other recruiting trials for Depressive Disorder, Major
Currently open trials in the same condition.
NCT07227454 — A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
· Phase 3
· recruiting
NCT07258485 — A Study to Evaluate Sleep Electroencephalogram (EEG) Features (Brain Activity While Sleeping) in Participants With Major
· recruiting
NCT07059234 — The Motor Activity - Subjective Energy (MASE) Project
· NA
· recruiting
NCT06982820 — Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia
· NA
· recruiting
NCT05553353 — Dosing rTMS for Depression Post-SCI
· NA
· recruiting
Other Forest Laboratories trials
Trials by the same sponsor.
NCT02788617 — Evaluation of the Efficacy of Diafert in Predicting Embryos' Potential to Develop to the Blastocyst Stage
· completed
NCT02732327 — Comparative Study of Ceftazidime-Avibactam Versus Standard of Care as Therapy in Febrile Neutropenic Adults With Cancer
· Phase 2
· terminated
NCT02670538 — Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode
· Phase 3
· completed
NCT02670551 — Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depres
· Phase 3
· completed
NCT02559570 — A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Forest Laboratories
Last refreshed: 29 October 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02288325.