A Trial of Dextromethorphan for Treatment of Major Depressive Disorder

NCT02860962 | Completed Phase 1 DMC

• 1 other identifier: Pro00052508
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

Brief Summary

A proof-of-concept study to determine the antidepressant potential of Dextromethorphan for treating depression associated with Major Depressive Disorder in inpatients.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Montgomery-Åsberg Depression Rating Scale (MADRS)

  Examiner-rated scale of depression severity

  Several assessments over the course of 24-36 hours, and during follow-up visit during the following week

Study Arms (2)

Dextromethorphan

ACTIVE COMPARATOR

2 doses of Dextromethorphan 75mg oral (PO), separated by 4 hours

Drug: Dextromethorphan Hydrobromide

Placebo

PLACEBO COMPARATOR

2 doses of placebo (oral/PO), separated by 4 hours

Drug: Dextromethorphan Hydrobromide

Interventions

Dextromethorphan Hydrobromide DRUG

Dose as a single capsule preparation formulated by the Investigational Drug Service of MUSC specifically for the purposes of this trial.

Dextromethorphan; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• Meet Diagnostic and Statistical Manual-IV criteria for current Major Depressive Disorder
• Be receiving inpatient treatment for an acute depressive episode
• Have voluntarily hospitalization status
• Have Patient Health Questionnaire (PHQ-9) score of 10 or greater
• Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments.
• Must consent to random assignment and be willing to commit to medication treatment and follow-up assessments.
• Negative Urine Drug Screen and Blood Alcohol Level

You may not qualify if:

• A primary psychiatric diagnosis other than Major Depressive Disorder or presence of psychotic features associated with current or past major depressive episodes
• History of drug induced mania
• Diagnosis of substance use disorder, as assessed through electronic chart review, or elucidated during screening process
• Current use of opioids including tramadol, amphetamines/sympathomimetics, or benzodiazepines, prescription or otherwise
• Abnormal (out of MUSC reference range) kidney function, or liver function \> 3x upper limit of normal as per most recent blood work (in inpatient setting either assessed at time of admission, or during the hospitalization)
• Known pregnancy or positive urine pregnancy test, or breast-feeding
• History of hypertension, stroke, heart failure, myocardial infarction, Serotonin Syndrome, pulmonary disease, or any currently uncontrolled medical condition that may adversely affect the conduct of the trial or jeopardize the safety of the subject as assessed by research team and or inpatient treatment team
• Concomitant use of a Monoamine Oxidase Inhibitor or Linezolid (currently, or within 2 weeks of screening)
• Concomitant use Fluoxetine, Paroxetine, Quinidine, Cinacalcet, or Ritonavir
• Concomitant use of Memantine, Amantadine, or Ketamine
• Greater than one serotonergic antidepressant medication (defined as a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, Tricyclic Antidepressant, or Mirtazapine)
• A serotonergic antidepressant (defined as a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, Tricyclic Antidepressant, or Mirtazapine) medication plus any of the following medications: triptans, ergotamines, metoclopramide, buspirone, trazodone, cyclobenzaprine, lithium, or lorcaserin
• Allergy to or contraindicated use of Dextromethorphan or its excipients

Sponsors & Collaborators

• Medical University of South Carolina: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Dextromethorphan

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Sudie E. Back, Ph.D.

  Director of Drug and Alcohol Research Track at the Medical University of South Carolina

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 10, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 25, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share