Your session is about to expire
← Back to Search
NMDA Receptor Antagonist
Ketamine for Depression
Phase 1
Recruiting
Research Sponsored by West Virginia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14-day dosing period.
Awards & highlights
Study Summary
This trial is testing whether a form of ketamine that's easier to administer than intravenous ketamine can effectively treat depression in people who have recently had a stroke, with fewer side effects.
Eligible Conditions
- Depression
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14-day dosing period.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14-day dosing period.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in depressive symptoms measured by the MADRS-S.
Change in depressive symptoms measured by the MADRS.
Secondary outcome measures
Side effects will be evaluated using the PRISE.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ketamine doseExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1090
Find a Location
Who is running the clinical trial?
West Virginia UniversityLead Sponsor
174 Previous Clinical Trials
56,185 Total Patients Enrolled
2 Trials studying Depression
540 Patients Enrolled for Depression
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
West Virginia
How old are they?
18 - 65
What site did they apply to?
WVU Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Share this study with friends
Copy Link
Messenger