Phase 2 Completed N=97 Randomized Quadruple-blind Treatment

Assessing Symptomatic Clinical Episodes in Depression

Major Depressive Disorder

Source: ClinicalTrials.gov NCT03595579 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2021

Primary outcomePrimary: MADRS Score - Overall Change From Baseline — 13.7; 8.8 score on a scale — p=<.001

Summary

Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.

Outcome Measures

Outcome	Result	p-value
PRIMARY MADRS Score - Overall Change From Baseline	13.7; 8.8	<.001 sig

Eligibility Criteria

Inclusion Criteria

Currently meets DSM-5 criteria for MDD
Body mass index (BMI) between 18 and 40 kg/m^2, inclusive
Agree to use adequate method of contraception for the duration of the study
Additional criteria may apply

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
Additional criteria may apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03595579). 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. Informational only — not medical advice.