NCT02741791 (STRIDE-1) is a Phase 3 clinical trial of AXS-05 in Treatment Resistant Major Depressive Disorder, sponsored by Axsome Therapeutics, Inc..

Who is sponsoring NCT02741791?

NCT02741791 is sponsored by Axsome Therapeutics, Inc..

What drugs are being tested in NCT02741791?

Interventions in NCT02741791: AXS-05, Bupropion.

What condition does NCT02741791 study?

NCT02741791 studies Treatment Resistant Major Depressive Disorder.

Is NCT02741791 still recruiting?

NCT02741791 is currently completed. Last updated 22 March 2021.

Last reviewed 2021-03-22 · How we verify

NCT02741791: STRIDE-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 22 March 2021

What this trial tests

Phase 3 trial testing AXS-05 in Treatment Resistant Major Depressive Disorder in 312 participants. Completed in 20 March 2020.

Timeline

1 March 2016

Primary endpoint
20 March 2020

20 March 2020

Quick facts

Lead sponsor	Axsome Therapeutics, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	312
Start date	1 March 2016
Primary completion	20 March 2020
Estimated completion	20 March 2020
Sites	74 locations across United States

Drugs / interventions tested

AXS-05 — full drug profile →
Bupropion (bupropion) — full drug profile →

Conditions studied

Treatment Resistant Major Depressive Disorder — all drugs for Treatment Resistant Major Depressive Disorder →

Sponsor

Axsome Therapeutics, Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Treatment Resistant Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Time frame: 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

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Glutamatergic Dysfunction and Glutamatergic Compounds for Major Psychiatric Disorders: Evidence From Clinical Neuroimaging Studies.
Li CT, Yang KC, Lin WC. · · 2018 · cited 118× · PMID 30733690 · DOI 10.3389/fpsyt.2018.00767
A new generation of antidepressants: an update on the pharmaceutical pipeline for novel and rapid-acting therapeutics in mood disorders based on glutamate/GABA neurotransmitter systems.
Wilkinson ST, Sanacora G. · · 2019 · cited 111× · PMID 30447328 · DOI 10.1016/j.drudis.2018.11.007
Glutamatergic Neurotransmission: Pathway to Developing Novel Rapid-Acting Antidepressant Treatments.
Kadriu B, Musazzi L, Henter ID, Graves M, et al · · 2019 · cited 110× · PMID 30445512 · DOI 10.1093/ijnp/pyy094
Novel Glutamatergic Modulators for the Treatment of Mood Disorders: Current Status.
Henter ID, Park LT, Zarate CA. · · 2021 · cited 104× · PMID 33904154 · DOI 10.1007/s40263-021-00816-x
The future of psychopharmacology: a critical appraisal of ongoing phase 2/3 trials, and of some current trends aiming to de-risk trial programmes of novel agents.
Correll CU, Solmi M, Cortese S, Fava M, et al · · 2023 · cited 90× · PMID 36640403 · DOI 10.1002/wps.21056
Novel drug developmental strategies for treatment-resistant depression.
Borbély É, Simon M, Fuchs E, Wiborg O, et al · · 2022 · cited 70× · PMID 34822719 · DOI 10.1111/bph.15753
Experimental medication treatment approaches for depression.
Ionescu DF, Papakostas GI. · · 2017 · cited 39× · PMID 28323287 · DOI 10.1038/tp.2017.33
Clinical specificity profile for novel rapid acting antidepressant drugs.
Scala M, Fanelli G, De Ronchi D, Serretti A, et al · · 2023 · cited 33× · PMID 37381161 · DOI 10.1097/yic.0000000000000488

Verify or expand the search:

Other trials of AXS-05

Trials testing the same drug.

NCT05557409 — A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation · Phase 3 · completed
NCT04797715 — Assessing Clinical Outcomes in Alzheimer's Disease Agitation · Phase 3 · completed
NCT04608396 — Mechanistic Evaluation of Response in TRD (MERIT) · Phase 2 · completed
NCT04019704 — A Trial of AXS-05 in Patients With Major Depressive Disorder · Phase 3 · completed
NCT03595579 — Assessing Symptomatic Clinical Episodes in Depression · Phase 2 · completed

Other Axsome Therapeutics, Inc. trials

Trials by the same sponsor.

NCT06736509 — An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE- · Phase 3 · terminated
NCT06360419 — Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol · Phase 3 · completed
NCT05972044 — A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS) · Phase 3 · completed
NCT05557409 — A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation · Phase 3 · completed
NCT05550207 — Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGR · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02741791 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Axsome Therapeutics, Inc.
Last refreshed: 22 March 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02741791.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing