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

Phase 3

Completed

• Conditions: Depression; Major Depressive Disorder
• Interventions: Drug: Placebo; Drug: AXS-05

• Registration Number: NCT04019704
• Lead Sponsor: Axsome Therapeutics, Inc.

Brief Summary

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

Detailed Description

This study will evaluate AXS-05 in a randomized, double-blind, placebo-controlled study in patients with MDD. Eligible patients will be randomized in a 1:1 ratio to treatment with AXS-05 or placebo for 6 weeks.

Study Timeline

• Study Start: 2019-06-20
• Study First Submitted: 2019-07-11
• Study First Submitted QC: 2019-07-11
• Study First Posted: 2019-07-15
• Primary Completion: 2019-11-26
• Study Completion: 2019-12-05
• Disposition First Submitted: 2020-12-07
• Disposition First Submitted QC: 2020-12-08
• Disposition First Posted: 2020-12-10
• Status Verified: 2022-09
• Results First Submitted: 2022-09-16
• Results First Submitted QC: 2022-09-16
• Last Update Submitted: 2022-09-16
• Results First Posted: 2022-10-12
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 327

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo oral tablets to match AXS-05
AXS-05	AXS-05	AXS-05 (bupropion and dextromethorphan) oral tablets

Primary Outcome Measures

Name	Time	Method
Change in MADRS Total Score From Baseline to Week 6	6 weeks	The primary objective of the study was to evaluate the efficacy of AXS-05 as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms from baseline to Week 6. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.

Trial Locations

Locations (1)

Clinical Research Site; 🇺🇸 Everett, Washington, United States