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NCT04226352 · ClinicalTrials.gov registry record · Phase 1
Three Dosing Regimens of Dextromethorphan (DXM) Reportedly Used in Major Depressive Disorder
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT04226352: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT04226352 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04226352, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
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.
Primary Outcome
This will be measured in days from the first administration of the drug until discontinuation.
Interventions
- DRUG Dextromethorphan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2020-03-15 |
| Est. Completion | 2021-12-07 |
| Phase | Phase 1 |
What the finished NCT04226352 record still lists
NCT04226352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Dextromethorphan is the first listed.
NCT04226352 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04226352 about?
NCT04226352 is a clinical study titled "Three Dosing Regimens of Dextromethorphan (DXM) Reportedly Used in Major Depressive Disorder". 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 2...
What is the current status of trial NCT04226352?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2020-03-15. Estimated completion is 2021-12-07.
What interventions are being tested in trial NCT04226352?
The interventions under investigation include: Dextromethorphan (DRUG).
Who is sponsoring clinical trial NCT04226352?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04226352's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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