Back to resultsUse of Transmucosal Ketamine in Post Stroke Depression
Primary Purpose
Post-stroke Depression
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Sponsored by
About this trial
This is an interventional treatment trial for Post-stroke Depression
Eligibility 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
Sites / Locations
- WVU MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ketamine dose
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in depressive symptoms measured by the MADRS.
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.
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
Side effects will be evaluated using the PRISE.
Patient-Rated Inventory of Side Effects (PRISE), perceived tolerance per patient report
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04876066
Brief Title
Use of Transmucosal Ketamine in Post Stroke Depression
Official Title
Use of Transmucosal Ketamine in Post Stroke Depression
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
21 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketamine dose
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
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 Information:
Title
Change in depressive symptoms measured by the MADRS.
Description
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.
Time Frame
14-day dosing period.
Title
Change in depressive symptoms measured by the MADRS-S.
Description
Montgomery Asberg Depression Rating Scale Self-assessment (MADRS-S). The overall score ranges from 0-54 with a higher scores indicating more depression.
Time Frame
14-day dosing period.
Secondary Outcome Measure Information:
Title
Side effects will be evaluated using the PRISE.
Description
Patient-Rated Inventory of Side Effects (PRISE), perceived tolerance per patient report
Time Frame
14-day dosing period.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amelia Adcock
Phone
(304) 293-3527
Email
akadcock@hsc.wvu.edu
Facility Information:
Facility Name
WVU Medicine
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Use of Transmucosal Ketamine in Post Stroke Depression
We'll reach out to this number within 24 hrs