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

NCT03446846 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2020-12-17

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Minerva Neurosciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-30
Primary Completion
2019-11-21
Completion
2019-12-13
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Finland
  • Georgia
  • Moldova
  • Poland
  • Ukraine

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03446846 on ClinicalTrials.gov