Use of Transmucosal Ketamine in Post Stroke Depression

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

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

United States, West Virginia

WVU Medicine; Recruiting

Morgantown, West Virginia, United States, 26506

Sponsors and Collaborators

West Virginia University

More Information

• Responsible Party: Amelia Adcock, Associate Professor, West Virginia University
• ClinicalTrials.gov Identifier: NCT04876066
• Other Study ID Numbers: 1903509572
• First Posted: May 6, 2021
• Last Update Posted: May 6, 2021
• Last Verified: March 2021

• 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:

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