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



Status:Recruiting
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:11/16/2018
Start Date:March 2016
End Date:March 2019
Contact:Cheryl Askew
Email:stride-1@axsome.com
Phone:Study Director

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STRIDE-1: A Randomized, Double-blind, Active-controlled Trial to Assess the Efficacy and Safety of AXS-05 Administered Orally to Subjects With Treatment Resistant Major Depressive Disorder

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.


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
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