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

Axsome Therapeutics, Inc.312 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

312

Conditions

Treatment Resistant Major Depressive Disorder

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Key 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

Locations (74)

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Little Rock, Arkansas, United States

Unnamed facility

Anaheim, California, United States

Unnamed facility

Beverly Hills, California, United States

Unnamed facility

Garden Grove, California, United States

Unnamed facility

Outcomes

Primary Outcomes

Montgomery-Åsberg Depression Rating Scale (MADRS) total score

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.

Time frame: MADRS change from Baseline to End of Study (6 weeks)

Secondary Outcomes

Clinical Global Impressions-Severity (CGI-S)

Time frame: Baseline to End of Study (6 weeks)

Hamilton Depression Rating Scale - 17 items (HAMD-17)

Time frame: Baseline to End of Study (6 weeks)