Use of Transmucosal Ketamine in Post Stroke Depression

Last updated: April 28, 2022
Sponsor: West Virginia University
Overall Status: Active - Recruiting

Phase

1

Condition

Depression

Stroke

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT04876066
1903509572
  • Ages > 18
  • All Genders

Study 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 trials examining its use in Post Stroke Depression (PSD). There have been only few studies that have used other routes of administration (i.e., oral, transmucosal, intranasal, intramuscular) of ketamine which provided symptom relief for depression. The purpose of this study is to assess the effectiveness and safety of use of transmucosal ketamine in treatment of PSD. We hypothesize that fast acting antidepressant effects can be achieved with tolerable side effects for translation into the general post-stroke population. To test our hypothesis, the specific aim is to: (1) demonstrate that transmucosal administration of ketamine is feasible within the post-stroke depression population and has tolerable side effects. Exploratory aims will include assessment if ketamine also produces fast acting antidepressant effects.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women (18 years of age or older) of any ethnicity diagnosed with MajorDepressive 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 ornoncompliant with anti-depressive medications).
  • Willing to take the study drug ketamine on 2 separate occasions and comply withinstructions for testing.
  • Understands and willing to undergo risks associated with adverse effects of studymedications.
  • Willing to comply with restrictions and instructions disclosed in the consent form.

Exclusion

Exclusion Criteria:

  • Patients with blood pressure over 150 systolic or heart rate over 110 on day ofmedication 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

Study Design

Total Participants: 21
Study Start date:
November 30, 2020
Estimated Completion Date:
November 30, 2022

Connect with a study center

  • WVU Medicine

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

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