NCT04226352 is a Phase 1 clinical trial of Dextromethorphan in MDD, sponsored by Johns Hopkins University.

Who is sponsoring NCT04226352?

NCT04226352 is sponsored by Johns Hopkins University.

What drugs are being tested in NCT04226352?

Interventions in NCT04226352: Dextromethorphan.

What condition does NCT04226352 study?

NCT04226352 studies MDD, Treatment Resistant Depression, Smoking Cessation, Smoking.

Is NCT04226352 still recruiting?

NCT04226352 is currently completed. Last updated 4 November 2022.

Last reviewed 2022-11-04 · How we verify

NCT04226352

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

Three Dosing Regimens of Dextromethorphan (DXM) Reportedly Used in Major Depressive Disorder

Completed Phase 1 Last updated 4 November 2022

What this trial tests

Phase 1 trial testing Dextromethorphan in MDD in 5 participants. Completed in 7 December 2021.

Timeline

15 March 2020

Primary endpoint
7 December 2021

7 December 2021

Quick facts

Lead sponsor	Johns Hopkins University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	5
Start date	15 March 2020
Primary completion	7 December 2021
Estimated completion	7 December 2021
Sites	1 location across United States

Drugs / interventions tested

Dextromethorphan — full drug profile →

Conditions studied

MDD — all drugs for MDD →
Treatment Resistant Depression — all drugs for Treatment Resistant Depression →
Smoking Cessation — all drugs for Smoking Cessation →
Smoking — all drugs for Smoking →

Sponsor

Johns Hopkins University

Who can join

Adults 18 to 50, any sex, with MDD or Treatment Resistant Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label dosing pilot study of 15 patients aged 18-50 years of age with diagnoses of Major Depressive Disorder (MDD) randomized to 1 of 3 treatment arms. The study will consist of a screening evaluation performed within the course of 2 weeks, followed by an active treatment period of 28 days where treatment arm 1 will take a supervised dose of 300mg DXM every 14 days for 28 days, treatment arm 2 will take the FDA approved maximum daily ingestion for cough (60mg DXM) daily for 28 days, and treatment arm 3 will take 1 supervised dose of 300mg DXM and 60mg for the remaining 28 days. After the active treatment period, subjects will be followed for 65 days with safety and psychiatric assessments at designated timepoints.

Publications & conference data

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

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
Intrinsic Connectivity Networks of Glutamate-Mediated Antidepressant Response: A Neuroimaging Review.
Demchenko I, Tassone VK, Kennedy SH, Dunlop K, et al · · 2022 · cited 26× · PMID 35722550 · DOI 10.3389/fpsyt.2022.864902

Verify or expand the search:

Other trials of Dextromethorphan

Trials testing the same drug.

NCT07241065 — A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Dextromethorphan (CYP2D6 Substrate) in · Phase 1 · recruiting
NCT05068791 — Psilocybin-facilitated Treatment for Chronic Pain · EARLY_PHASE1 · recruiting
NCT05944510 — Dextromethorphan as an Augmentation Agent in Treatment-resistant Schizophrenia · Phase 4 · completed
NCT05699993 — A Study of IBI351 in Healthy Subjects · Phase 1 · completed
NCT05947604 — DDI Study of Single Oral Dose of Acoziborole With Sequential Co-administration of Midazolam and Dextromethorphan · Phase 1 · completed

Other recruiting trials for MDD

Currently open trials in the same condition.

NCT07422844 — Dynamic Network Response to TMS Treatment · recruiting
NCT07111390 — Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD) · NA · recruiting
NCT06828887 — Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LV232 Capsules in the Treatment of MDD · Phase 2 · recruiting
NCT06132178 — Psilocybin rTMS for Treatment Resistant Depression · Phase 2 · recruiting
NCT07269964 — At-Home tDCS as Maintenance Therapy · NA · recruiting

Other Johns Hopkins University trials

Trials by the same sponsor.

NCT06236542 — Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety · NA · not yet recruiting
NCT07532252 — Daridorexant for Alcohol Use Disorder · Phase 2 · not yet recruiting
NCT06687655 — Impact of Exogenous Ketones on Sleep Apnea · Phase 1, PHASE2 · not yet recruiting
NCT07079111 — 3D Printed Occlusal Splints for Intraoperative Use · NA · not yet recruiting
NCT02998502 — The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens · NA · not yet recruiting

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 NCT04226352 (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 Johns Hopkins University
Last refreshed: 4 November 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/NCT04226352.

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