Phase 3 N=327 Randomized Quadruple-blind Treatment

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

Depression · Major Depressive Disorder

Bottom Line

View on ClinicalTrials.gov: NCT04019704 ↗

Enrolled (actual)

327

Serious AEs

0.3%

Results posted

Oct 2022

Primary outcome: Primary: Change in MADRS Total Score From Baseline to Week 6 — 15.91; 12.04 score on a scale — p=0.002

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: AXS-05 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Axsome Therapeutics, Inc.
Primary completion: Nov 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in MADRS Total Score From Baseline to Week 6	15.91; 12.04	0.002 sig

Summary

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

Eligibility Criteria

Key Inclusion Criteria

Age 18 - 65
Currently meets DSM-5 criteria for MDD
Body Mass Index between 18 and 40 kg/m^2, inclusive

Key Exclusion Criteria

Suicide risk
History of treatment resistance in current depressive episode
History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months
Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04019704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.