A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder

Phase 3

Completed

• Conditions: Treatment Resistant Major Depressive Disorder
• Interventions: Drug: AXS-05; Drug: Bupropion

• Registration Number: NCT02741791
• Lead Sponsor: Axsome Therapeutics, Inc.

Brief Summary

To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with treatment resistant major depressive disorder (MDD).

This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting of an open-label, bupropion lead-in period, and a double-blind treatment period. The trial is being conducted in subjects with treatment resistant MDD.

Subjects will be considered to have treatment resistant MDD if they have had a historical inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate response to treatment with bupropion during the open-label, lead-in period.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-18
• Primary Completion: 2020-03-20
• Study Completion: 2020-03-20
• Status Verified: 2021-03
• Disposition First Submitted: 2021-03-19
• Disposition First Submitted QC: 2021-03-22
• Last Update Submitted: 2021-03-22
• Disposition First Posted: 2021-03-24
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

Inclusion Criteria

• Currently meets DSM-V criteria for MDD
• History of inadequate response to 1 or 2 adequate antidepressant treatments
• Body mass index (BMI) between 18 and 40 kg/m2, inclusive
• Agree to use adequate method of contraception for the duration of the study
• Additional criteria may apply

Key

Exclusion Criteria

• Suicide risk
• Treatment with any investigational drug within 6 months
• History of electroconvulsive therapy (ECT), 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AXS-05	AXS-05	-
Bupropion	Bupropion	-

Primary Outcome Measures

Name	Time	Method
Montgomery-Åsberg Depression Rating Scale (MADRS) total score	MADRS change from Baseline to End of Study (6 weeks)	The MADRS is used to assess depressive symptomatology during the previous week. Subjects are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impressions-Severity (CGI-S)	Baseline to End of Study (6 weeks)
Hamilton Depression Rating Scale - 17 items (HAMD-17)	Baseline to End of Study (6 weeks)