Three Dosing Regimens of Dextromethorphan (DXM) Reportedly Used in Major Depressive Disorder
Primary Purpose
MDD, Treatment Resistant Depression, Smoking Cessation
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dextromethorphan
Sponsored by
About this trial
This is an interventional other trial for MDD
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins Department of Psychiatry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Dose 1
Dose 2
Dose 3
Arm Description
60 mg DXM a day for 28 days
300 mg DXM every 2 weeks for 28 days.
300mg DXM once, with 60mg DXM daily afterwards
Outcomes
Primary Outcome Measures
Time to All-Cause Discontinuation of Dextromethorphan
This will be measured in days from the first administration of the drug until discontinuation.
Secondary Outcome Measures
Full Information
NCT ID
NCT04226352
First Posted
January 9, 2020
Last Updated
November 1, 2022
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT04226352
Brief Title
Three Dosing Regimens of Dextromethorphan (DXM) Reportedly Used in Major Depressive Disorder
Official Title
An Open-Label Tolerance Study of Three Dosing Regimens of Dextromethorphan (DXM) Reportedly Used in Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2020 (Actual)
Primary Completion Date
December 7, 2021 (Actual)
Study Completion Date
December 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MDD, Treatment Resistant Depression, Smoking Cessation, Smoking
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose 1
Arm Type
Experimental
Arm Description
60 mg DXM a day for 28 days
Arm Title
Dose 2
Arm Type
Experimental
Arm Description
300 mg DXM every 2 weeks for 28 days.
Arm Title
Dose 3
Arm Type
Experimental
Arm Description
300mg DXM once, with 60mg DXM daily afterwards
Intervention Type
Drug
Intervention Name(s)
Dextromethorphan
Intervention Description
Dextromethorphan will be administered and its tolerability evaluated.
Primary Outcome Measure Information:
Title
Time to All-Cause Discontinuation of Dextromethorphan
Description
This will be measured in days from the first administration of the drug until discontinuation.
Time Frame
Up to 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anupama Kumar
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Department of Psychiatry
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Three Dosing Regimens of Dextromethorphan (DXM) Reportedly Used in Major Depressive Disorder
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