MedTrace Logo

A Trial of AXS-05 in Patients With Major Depressive Disorder

NCT04019704 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 327

Last updated 2022-10-12

Study results available
· View outcomes & findings →

Summary

A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).

Conditions

Interventions

DRUG

AXS-05

Oral AXS-05 tablets, taken daily for 6 weeks.

DRUG

Placebo

Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.

Sponsors & Collaborators

  • Axsome Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-06-20
Primary Completion
2019-11-26
Completion
2019-12-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04019704 on ClinicalTrials.gov