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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT04226352

Public ClinicalTrials.gov record NCT04226352. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 19, 2026, 4:39 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label Tolerance Study of Three Dosing Regimens of Dextromethorphan (DXM) Reportedly Used in Major Depressive Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04226352
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Johns Hopkins University
Other
Enrollment
5 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 50 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 14, 2020
Primary completion
Dec 6, 2021
Completion
Dec 6, 2021
Last update posted
Nov 3, 2022

2020 – 2021

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Johns Hopkins Department of Psychiatry Baltimore Maryland 21287

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04226352, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 3, 2022 · Synced Sep 19, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04226352 live on ClinicalTrials.gov.

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