Use of Transmucosal Ketamine in Post Stroke Depression

Post-stroke Depression Clinical Trial

Official title:

Use of Transmucosal Ketamine in Post Stroke Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04876066
• Other study ID #: 1903509572
• Status: Recruiting
• Phase: Phase 1
• Start date: November 30, 2020
• Est. completion date: November 2022

Study information

• Verified date: April 2022
• Source: West Virginia University
• Contact: Amelia Adcock
• Phone: (304) 293-3527
• Email: akadcock[@]hsc.wvu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Post-stroke Depression
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	WVU Medicine	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	14-day dosing period.
Primary	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.	14-day dosing period.
Secondary	Side effects will be evaluated using the PRISE.	Patient-Rated Inventory of Side Effects (PRISE), perceived tolerance per patient report	14-day dosing period.