NCT04226352

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• MDD
• Treatment Resistant Depression
• Smoking Cessation
• Smoking

Interventions

Type	Name	Description
DRUG	Dextromethorphan	Dextromethorphan will be administered and its tolerability evaluated.

Timeline

• Start date: 2020-03-15
• Primary completion: 2021-12-07
• Completion: 2021-12-07
• First posted: 2020-01-13
• Last updated: 2022-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study