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NMDA Receptor Antagonist
Low Ketamine, TS-134 for Healthy Subjects
Phase 1
Waitlist Available
Led By Joshua Kantrowitz, MD
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and day 4
Awards & highlights
Summary
This trialwill test the effectiveness of ketamine & a drug called TS-134 to treat depression in 120 people.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and day 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and day 4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brief Psychiatric Rating Scale (BPRS)
Final PharmacoBOLD signals in pre-specified ROIs
Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Medium Ketamine, TS-134Experimental Treatment2 Interventions
Two administrations of ketamine 0.125 mg/kg pre post 4 days of TS-134 20 mg
Group II: Low Ketamine, TS-134Experimental Treatment2 Interventions
Two administrations of ketamine 0.06 mg/kg pre post 4 days of TS-134 20 mg
Group III: High Ketamine, TS-134Experimental Treatment2 Interventions
Two administrations of ketamine 0.23 mg/kg pre post 4 days of TS-134 20 mg
Group IV: Low Ketamine, placeboPlacebo Group2 Interventions
Two administrations of ketamine 0.06 mg/kg pre post 4 days of placebo
Group V: High ketamine, placeboPlacebo Group2 Interventions
Two administrations of ketamine 0.23 mg/kg pre post 4 days of placebo
Group VI: Medium Ketamine, placeboPlacebo Group2 Interventions
Two administrations of ketamine 0.125 mg/kg pre post 4 days of placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1120
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
New York State Psychiatric InstituteLead Sponsor
475 Previous Clinical Trials
153,535 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,820 Previous Clinical Trials
2,692,699 Total Patients Enrolled
Joshua Kantrowitz, MDPrincipal InvestigatorNYSPI
1 Previous Clinical Trials
24 Total Patients Enrolled
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