Major Depressive Disorder Clinical Trial
Official title:
A Double-Blind Placebo-Controlled Trial of Dextromethorphan for Treatment of Major Depressive Disorder
NCT number | NCT02860962 |
Other study ID # | Pro00052508 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | June 2017 |
Verified date | October 2018 |
Source | Medical University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A proof-of-concept study to determine the antidepressant potential of Dextromethorphan for treating depression associated with Major Depressive Disorder in inpatients.
Status | Completed |
Enrollment | 4 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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