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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

Study Summary

This trialwill test the effectiveness of ketamine & a drug called TS-134 to treat depression in 120 people.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and day 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and day 4 for reporting.

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
~1090

Find a Location

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
474 Previous Clinical Trials
153,137 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,779 Previous Clinical Trials
2,674,522 Total Patients Enrolled
Joshua Kantrowitz, MDPrincipal InvestigatorNYSPI
1 Previous Clinical Trials
24 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I have the proper qualifications to join this clinical trial?

"This clinical trial is accepting approximately 120 individuals between ages 18 and 55 who possess healthy physiological characteristics."

Answered by AI

Has High Ketamine, TS-134 been granted clearance from the FDA?

"As it is a phase 1 trial with no substantial data in regards to its safety and efficacy, High Ketamine TS-134 garnered a score of one."

Answered by AI

How many people is the trial recruiting?

"Affirmative. According to clinicaltrials.gov, this medical trial is currently recruiting patients and opened for enrolment on October 1st 2022. The listing was last amended in January 3rd 2023 and seeks 120 participants at one research facility."

Answered by AI

Is enrollment for this research endeavor restricted to adults only?

"This clinical trial states that only patients between 18 to 55 years of age are eligible. Patients under the legal age and seniors over 65 can take part in other studies, totaling 393 such opportunities."

Answered by AI

Are there any open enrolment slots for this investigation?

"Affirmative. Information hosted on clinicaltrials.gov indicates that as of now, the study is still recruiting patients. This research initiative was initially posted on October 1st 2022 with the last edit being made in January 3rd 2023 and it requires 120 participants at a single location to be admitted."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
NYSPI
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. NYSPI: < 48 hours
~56 spots leftby Aug 2025