NCT03446846

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

A Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (5.0 mg or 2.5 mg) of MIN-117 in Adult Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Minerva Neurosciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	MIN-117 5.0 mg	5.0 mg MIN-117 administered as two MIN-117 2.5 mg capsules as a single dose once daily
DRUG	MIN-117 2.5 mg	2.5 mg MIN-117 administered as one MIN-117 2.5 mg capsule and one Placebo capsule as a single dose once daily
DRUG	Placebo	Placebo administered as two Placebo capsules as a single dose once daily

Timeline

• Start date: 2018-03-30
• Primary completion: 2019-11-21
• Completion: 2019-12-13
• First posted: 2018-02-27
• Last updated: 2020-12-17
• Results posted: 2020-12-17

Locations

47 sites across 7 countries: United States, Bulgaria, Finland, Georgia, Moldova, Poland, Ukraine

Regulatory

• FDA-regulated drug study