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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02741791

Acronym

STRIDE-1

Enrollment

312

Registered

2016-04-18

Start date

2016-03-31

Completion date

2020-03-20

Last updated

2021-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment Resistant Major Depressive Disorder

Keywords

AXS-05, Major Depressive Disorder, Treatment Resistant Depression, TRD, MDD, Axsome, NMDA receptor, Refractory depression, Resistant depression, Depression

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.

Interventions

DRUGAXS-05

AXS-05 taken daily for 6 weeks.

DRUGBupropion

Buproprion taken daily for 6 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026