Status:
UNKNOWN
Use of Transmucosal Ketamine in Post Stroke Depression
Lead Sponsor:
West Virginia University
Conditions:
Post-stroke Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Studies have shown that ketamine is very effective and has a quick onset in treatment of depression. Most of these studies used intravenous ketamine in an inpatient setting and there are no large tria...
Eligibility Criteria
Inclusion
- Men and women (18 years of age or older) of any ethnicity diagnosed with Major Depressive Disorder (DSM-V criteria), who have had failed to respond to prior therapy (as defined as at least one anti-depressant trial or patient was intolerant or noncompliant with anti-depressive medications).
- Willing to take the study drug ketamine on 2 separate occasions and comply with instructions for testing.
- Understands and willing to undergo risks associated with adverse effects of study medications.
- Willing to comply with restrictions and instructions disclosed in the consent form.
Exclusion
- Patients with blood pressure over 150 systolic or heart rate over 110 on day of medication administration
- Patients with a diagnosis of epilepsy
- Patients with a significant history of high intraocular pressure.
- Patients with life threatening medical problems.
- Participant is pregnant or breastfeeding.
- Infants and children
- Patients who lack medical decision-making capacity
- Patients who would require medication adjustment during time in the study.
- Known hypersensitivity to the study drug (ketamine).
- Unwilling to undergo risks associated with adverse effects of study drugs.
- Unwilling to comply with restrictions and instructions disclosed in the consent form
Key Trial Info
Start Date :
November 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04876066
Start Date
November 30 2020
End Date
November 1 2022
Last Update
April 29 2022
Active Locations (1)
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1
WVU Medicine
Morgantown, West Virginia, United States, 26506