NCT04608396 (MERIT) is a Phase 2 clinical trial of AXS-05 in Treatment Resistant Depression, sponsored by Axsome Therapeutics, Inc..

Who is sponsoring NCT04608396?

NCT04608396 is sponsored by Axsome Therapeutics, Inc..

What drugs are being tested in NCT04608396?

Interventions in NCT04608396: AXS-05, Placebo.

What condition does NCT04608396 study?

NCT04608396 studies Treatment Resistant Depression, Major Depressive Disorder.

Is NCT04608396 still recruiting?

NCT04608396 is currently completed. Last updated 12 July 2022.

Last reviewed 2022-07-12 · How we verify

NCT04608396: MERIT

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

Mechanistic Evaluation of Response in TRD (MERIT)

Completed Phase 2 Last updated 12 July 2022

What this trial tests

Phase 2 trial testing AXS-05 in Treatment Resistant Depression in 44 participants. Completed in 30 July 2021.

Timeline

13 August 2020

Primary endpoint
30 July 2021

30 July 2021

Quick facts

Lead sponsor	Axsome Therapeutics, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	44
Start date	13 August 2020
Primary completion	30 July 2021
Estimated completion	30 July 2021
Sites	20 locations across United States

Drugs / interventions tested

AXS-05 — full drug profile →
Placebo

Conditions studied

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

Sponsor

Axsome Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with Treatment Resistant Depression or Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To evaluate the relapse prevention of AXS-05 relative to placebo in subjects with treatment resistant depression (TRD). This is a randomized, double-blind, placebo-controlled study to evaluate AXS-05 compared to placebo in delaying relapse of depressive symptoms in patients with TRD who are in stable remission after treatment with AXS-05.

Publications & conference data

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

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
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
Glutamatergic Modulators for Major Depression from Theory to Clinical Use.
McIntyre RS, Jain R. · · 2024 · cited 31× · PMID 39150594 · DOI 10.1007/s40263-024-01114-y
Novel Antidepressants in the Pipeline (Phase II and III): A Systematic Review of the US Clinical Trials Registry.
Sakurai H, Yonezawa K, Tani H, Mimura M, et al · · 2022 · cited 21× · PMID 35045580 · DOI 10.1055/a-1714-9097
Emerging Therapeutics Based on the Amino Acid Neurotransmitter System: An Update on the Pharmaceutical Pipeline for Mood Disorders.
Hecking J, Davoudian PA, Wilkinson ST. · · 2021 · cited 13× · PMID 34124495 · DOI 10.1177/24705470211020446
Investigational Drugs for the Treatment of Depression (Part 2): Glutamatergic, Cholinergic, Sestrin Modulators, and Other Agents.
Vasiliu O. · · 2022 · cited 9× · PMID 35847011 · DOI 10.3389/fphar.2022.884155
Molecular Mechanisms of Emerging Antidepressant Strategies: From Ketamine to Neuromodulation.
Kowalczyk M, Aebisher D, Szpara J, Czech S, et al · · 2025 · PMID 41516220 · DOI 10.3390/ijms27010344
Advancing depression treatment: the role of sigma receptor ligands.
Zhang P, Ning Z, Chen H, Chen J, et al · · 2025 · PMID 41378345 · DOI 10.3389/fnins.2025.1691987

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
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
NCT03471767 — AXS-05 Phase II Trial on Smoking Behavior · Phase 2 · completed

Other recruiting trials for Treatment Resistant Depression

Currently open trials in the same condition.

NCT07183748 — Psilocybin Microdosing With Psychotherapy for Treatment-Resistant Depression · Phase 2 · recruiting
NCT06938841 — Maintenance rTMS for Depression (Maitr-De) · NA · recruiting
NCT06236711 — Transcranial Direct Current Stimulation (tDCS) as an Adjunctive Treatment for Treatment Resistant Depression (TRD) · NA · active not recruiting
NCT05774665 — Specialized Pro-resolving Lipid Mediators and Treatment Resistant Depression · Phase 2 · active not recruiting
NCT06895863 — COpenhagen Magnetic Personalized Accelerated Brain Circuit Therapy for Treatment Resistant Depression · NA · recruiting

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 NCT04608396 (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: 12 July 2022

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/NCT04608396.

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