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Use of Transmucosal Ketamine in Post Stroke Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Post-stroke Depression Drug: Ketamine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
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
Official Title: Use of Transmucosal Ketamine in Post Stroke Depression
Actual Study Start Date : November 30, 2020
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04876066


Contacts
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Contact: Amelia Adcock (304) 293-3527 akadcock@hsc.wvu.edu

Locations
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United States, West Virginia
WVU Medicine Recruiting
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
West Virginia University
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Responsible Party: Amelia Adcock, Associate Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT04876066    
Other Study ID Numbers: 1903509572
First Posted: May 6, 2021    Key Record Dates
Last Update Posted: April 29, 2022
Last Verified: April 2022

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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
Additional relevant MeSH terms:
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Stroke
Depression
Depressive Disorder
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action