A Trial of Dextromethorphan for Treatment of Major Depressive Disorder

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Dextromethorphan

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