ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial of Dextromethorphan for Treatment of Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02860962
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

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

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Dextromethorphan Hydrobromide Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind Placebo-Controlled Trial of Dextromethorphan for Treatment of Major Depressive Disorder
Actual Study Start Date : August 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dextromethorphan
2 doses of Dextromethorphan 75mg oral (PO), separated by 4 hours
Drug: Dextromethorphan Hydrobromide
Dose as a single capsule preparation formulated by the Investigational Drug Service of MUSC specifically for the purposes of this trial.

Placebo Comparator: Placebo
2 doses of placebo (oral/PO), separated by 4 hours
Drug: Dextromethorphan Hydrobromide
Dose as a single capsule preparation formulated by the Investigational Drug Service of MUSC specifically for the purposes of this trial.




Primary Outcome Measures :
  1. Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Several assessments over the course of 24-36 hours, and during follow-up visit during the following week ]
    Examiner-rated scale of depression severity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. A primary psychiatric diagnosis other than Major Depressive Disorder or presence of psychotic features associated with current or past major depressive episodes
  2. History of drug induced mania
  3. Diagnosis of substance use disorder, as assessed through electronic chart review, or elucidated during screening process
  4. Current use of opioids including tramadol, amphetamines/sympathomimetics, or benzodiazepines, prescription or otherwise
  5. 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)
  6. Known pregnancy or positive urine pregnancy test, or breast-feeding
  7. 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
  8. Concomitant use of a Monoamine Oxidase Inhibitor or Linezolid (currently, or within 2 weeks of screening)
  9. Concomitant use Fluoxetine, Paroxetine, Quinidine, Cinacalcet, or Ritonavir
  10. Concomitant use of Memantine, Amantadine, or Ketamine
  11. Greater than one serotonergic antidepressant medication (defined as a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, Tricyclic Antidepressant, or Mirtazapine)
  12. 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
  13. Allergy to or contraindicated use of Dextromethorphan or its excipients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860962


Sponsors and Collaborators
Medical University of South Carolina
Investigators
Study Director: Sudie E. Back, Ph.D. Director of Drug and Alcohol Research Track at the Medical University of South Carolina

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02860962     History of Changes
Other Study ID Numbers: Pro00052508
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Disease
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Dextromethorphan
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs