A Study to Evaluate the Efficacy and Safety of MIN-117 in Adult Patients With Major Depressive Disorder

Summary

MIN-117C03 is a 6-week, 3-arm, randomized, double-blind, placebo controlled study to investigate the safety and efficacy of MIN-117 in male and female patients with Major Depressive Disorder, aged 18 to 65 years. Approximately 324 patients were to be randomly assigned to 1 of 3 treatment arms, including placebo, 2.5 mg MIN-117, or 5.0 mg MIN-117, in a 2:1:1 ratio.

Timeline

Start

2018-03-30

Primary completion

2019-11-21

Completion

2019-12-13

Outcome

Missed primary endpoint

release “MIN-117 study did not meet its primary (MADRS) and key secondary (HAM-A) endpoints” minervaneurosciences.com ↗

Drugs

Indications