Recruiting
Phase 1

Ketamine

Sponsor:

West Virginia University

Code:

NCT04876066

Conditions

Post-stroke Depression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ketamine

Study Details

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 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.

Conditions

Post-stroke Depression

Study ID

NCT04876066

Start date

Nov 30, 2020

Status verified date

Apr, 2022

Completion date

Nov, 2022

Anticipated

Primary completion date

Nov, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

21 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ketamine dose

The recommended ketamine dose of 0.5 mg/kg will be administered using a transmucosal route of administration wherein the subject will be instructed to place the liquid solution beneath their tongue and hold it in their mouth for 5 minutes. The pharmacy will prepare two 0.5 mg/kg solutions of ketamine in two syringes for each subject based on subject weight. For example, a 70 kg adult subject will receive a 0.35 mL solution of ketamine. The patient will receive a dose every 7 days for two weeks, for a total of two doses.

Interventions

Ketamine

Weight-based ketamine dose will be prepared and delivered personally to study physician or study personnel by pharmacy personnel as is done during standard protocol for use of ketamine not part of a clinical study.

Primary outcome measure

  • Change in depressive symptoms measured by the MADRS. [ Time Frame: 14-day dosing period. ]
  • Change in depressive symptoms measured by the MADRS-S. [ Time Frame: 14-day dosing period. ]

Central Contacts and Locations

Central contacts

Amelia Adcock

(304) 293-3527akadcock@hsc.wvu.edu

Locations

WVU Medicine

Recruiting

Morgantown, West Virginia, United States, 26506

More Information

Sponsor

West Virginia University

Last update posted

Apr 29, 2022

Last verified

Apr, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by West Virginia University on 2022-04-29.