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| Name | Class |
|---|---|
| Enovex Pharmacy | UNKNOWN |
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A retrospective chart review of an open-label trial of low-dose ketamine administered to front-line Healthcare workers who were identified as experiencing acute stress disorder due to the COVID-19 Pandemic.
An investigation of a novel, off-label use of an FDA approved drug (ketamine) in a low(micro) dose sublingual formulation of ketamine provided to front-line healthcare workers who were identified as suffering from acute stress disorder.
The study was conducted completely virtually via real-time telemedicine for physician visits and via asynchronous interaction for outcomes data collection.
Patients self-referred to the study via email outreach, and diagnosis was confirmed by medically validated screening assessments and study physician confirmation.
Once treatment was initiated, patients were seen via live telemedicine every 40 days while treatment response/outcomes data was collected weekly and monthly.
Patients were treated up to 120 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sublingual Micro-Dose Ketamine | Experimental | Ketamine micro-dose 37.5mg compounded sublingual daily administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sublingual Micro-Dose Ketamine | Drug | daily micro-dosing of frontline healthcare workers suffering from acute stress disorder due to the COVID-19 pandemic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient self-reported outcome measure | Perceived Stress Scale | up to 120 days |
| Patient self-reported outcome measure | 15-Dimensional Health-Related Quality of Life Questionnaire 15-Dimensional Health-Related Quality of Life Questionnaire | up to 120 days |
| Patient self-reported outcome measure | PCL-5 (PTSD checklist for DSM-5) | up to 120 days |
| Patient self-reported outcome measure | Physical Health- NIH PROMIS Global | up to 120 days |
| Patient self-reported outcome measure | Mental Health- NIH PROMIS Global | up to 120 days |
| Patient self-reported outcome measure | Health Perception and Social Roles | up to 120 days |
| Patient self-reported outcome measure | Doctor's Note | up to 120 days |
| Patient self-reported outcome measure | NIH PROMIS CAT- Depression | up to 120 days |
| Patient self-reported outcome measure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andre Atoian, MD | Limbic Medical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Limbic Medical | Toluca Lake | California | 91602 | United States |
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| ID | Term |
|---|---|
| D040701 | Stress Disorders, Traumatic, Acute |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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Retrospective, Open-label chart review
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NIH PROMIS CAT Neuro-QOL-Anxiety |
| up to 120 days |