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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
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for MDD

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 9, 2020
Last Updated
November 1, 2022
Sponsor
Johns Hopkins University
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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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