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Use of Transmucosal Ketamine in Post Stroke Depression

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ClinicalTrials.gov Identifier: NCT04876066
Recruitment Status : Recruiting
First Posted : May 6, 2021
Last Update Posted : April 29, 2022
Sponsor:
Information provided by (Responsible Party):
Amelia Adcock, West Virginia University

Tracking Information
First Submitted Date  ICMJE May 3, 2021
First Posted Date  ICMJE May 6, 2021
Last Update Posted Date April 29, 2022
Actual Study Start Date  ICMJE November 30, 2020
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2021)
  • Change in depressive symptoms measured by the MADRS. [ Time Frame: 14-day dosing period. ]
    The Montgomery-Asberg Depression Rating Scale is a ten-item diagnostic questionnaire used by mental health clinicians to measure the severity of depressive episodes in subjects with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. "Reduction of MADRS" = 50% drop in total score as compared to baseline, a score of 0-8 indicating NO depression OR a decrease from a more severe category to a more mild one.
  • Change in depressive symptoms measured by the MADRS-S. [ Time Frame: 14-day dosing period. ]
    Montgomery Asberg Depression Rating Scale Self-assessment (MADRS-S). The overall score ranges from 0-54 with a higher scores indicating more depression.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2021)
Side effects will be evaluated using the PRISE. [ Time Frame: 14-day dosing period. ]
Patient-Rated Inventory of Side Effects (PRISE), perceived tolerance per patient report
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Transmucosal Ketamine in Post Stroke Depression
Official Title  ICMJE Use of Transmucosal Ketamine in Post Stroke Depression
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
The study will be an open-label study of eligible male and female patients and minorities diagnosed with post stroke depression (PSD) conducted by West Virginia University faculty and research associates.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Post-stroke Depression
Intervention  ICMJE Drug: 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.
Study Arms  ICMJE 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.
Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 5, 2021)
21
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2022
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amelia Adcock (304) 293-3527 akadcock@hsc.wvu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04876066
Other Study ID Numbers  ICMJE 1903509572
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Amelia Adcock, West Virginia University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE West Virginia University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account West Virginia University
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP