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 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.

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Key information

Conditions

MDD Behavior Depressive Disorder Depressive Disorder, Treatment-Resistant Health Behavior Mental Disorders Mood Disorders Smoking Smoking Cessation Treatment Resistant Depression

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Johns Hopkins Department of Psychiatry

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject must be a man or woman, 18 to 50 years, inclusive
Subject must meet Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V) criteria for MDD without psychotic features based on clinician assessment.
Subjects must have undergone 3 or fewer antidepressant trials
Subjects must have moderate to severe depression as determined by a screening Montgomery-Åsberg Depression Rating Scale (MADRS) score of 20 or greater

Exclusion criteria

Subject has a current diagnosis of Bipolar Affective Spectrum Disorder, obsessive compulsive disorder, or a DSM-V personality disorder
Subject has had an incomplete response to more than 3 antidepressant trials
Subject cannot tolerate 60mg DXM as determined by study physician
Subject meets DSM-5 severity criteria for moderate or severe substance or alcohol use disorder within 6 months of screening, excluding caffeine or nicotine
Subject has a current clinical diagnosis of autism, dementia, or intellectual disability
Subject has history of psychosis not attributable to organic/metabolic causes
Subject has a history of serotonin syndrome or sensitivity
Subject has taken venlafaxine or a monoamine oxidase inhibitor (MAOI) within 4 weeks prior to screening
Subject is actively taking an opiate antagonist for any indication
Subject is taking a higher-than-recommended dosage of serotonergic antidepressant [including but not limited to selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI), serotonin partial agonist/reuptake inhibitor (SPARI), serotonin antagonist and reuptake inhibitor (SARI) within 4 weeks prior to screening
Subject is actively suicidal
Subject has participated in another clinical drug trial within 6 months prior to screening
Subject has a history or current signs of liver or renal insufficiency
Subject has a clinically significant condition of any organ system that might adversely impact subject health upon consumption of DXM
Subject has previous history of intolerance to ketamine or its enantiomers
Subject has previous history of incomplete antidepressant response to ketamine or its enantiomers
Subject is currently using DXM for any indication

Treatment and study plan

dextromethorphan

Drug

Dextromethorphan will be administered and its tolerability evaluated.

Primary outcomes

Time to All-Cause Discontinuation of Dextromethorphan

Time frame: Up to 90 days

This will be measured in days from the first administration of the drug until discontinuation.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Jan 13, 2020
Registry last updated: Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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