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
|Condition or disease||Intervention/treatment||Phase|
|Post-stroke Depression||Drug: Ketamine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|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)|
|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|
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.
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.
- 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.
- 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
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
|Contact: Amelia Adcock||(304) email@example.com|
|United States, West Virginia|
|Morgantown, West Virginia, United States, 26506|