A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder (STRIDE-1)

Axsome Therapeutics

Status and phase

Completed

Phase 3

Conditions

Treatment Resistant Major Depressive Disorder

Treatments

Drug: AXS-05

Drug: Bupropion

Study type

Interventional

Funder types

Industry

Identifiers

NCT02741791

AXS-05-301

Details and patient eligibility

About

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.

Enrollment

312 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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