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Ketamine and TS-134 Study in Healthy Volunteers

This study is looking for 120 healthy volunteers aged 18-55 to help researchers understand how certain drugs affect the brain. You would receive either TS-134 or a placebo (an inactive substance) for four days, along with ketamine during an MRI (magnetic resonance imaging) scan. The main goal is to see how these interventions change brain signals, measured by special MRI scans called pharmacoBOLD, and to assess your mental state using the Brief Psychiatric Rating Scale (BPRS). This research aims to find better ways to develop treatments for conditions like schizophrenia by understanding how drugs interact with brain pathways.

Study design
This study involves 120 healthy volunteers who will be randomly assigned to different groups receiving either TS-134 or a placebo, along with ketamine. It is an interventional study, meaning participants will receive specific treatments.
What's involved
You would have a screening period of up to 31 days, followed by a 4-day treatment period. During this time, you would undergo two pharmacoBOLD MRI sessions and have a follow-up visit.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a follow-up visit after the 4-day treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05401227

Glutamatergic Mechanisms: Aim2

Recruiting
PHASE1Ages 18–55InterventionalTreatment
New York State Psychiatric Institute
~120 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:KetamineTs-134Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Final PharmacoBOLD signals in pre-specified ROIs
Measured over Baseline and Day 4
+1 more outcome measured

Conditions

Healthy

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Healthy

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Joshua Kantrowitz, MD · PRINCIPAL_INVESTIGATOR · NYSPI

Who to contact

Joshua Kantrowitz
[email protected]
6467748477
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Contraindications to XT (urinary retention, moderate or severe hepatic impairment, gastric retention, untreated narrow-angle glaucoma, hypernasality)
renal problems (GFR\<60)
high blood pressure (defined as supine systolic blood pressure (SBP) \> 140 or supine diastolic blood pressure (DBP) \> 90)
low blood pressure (defined as supine SBP \< 100, DBP \< 60)
abnormal orthostatic blood pressure (change in mean arterial pressure \[1/3 systolic + 2/3 diastolic\] of \> 20% between supine and standing blood pressures)
clinically significant cardiac illness, as determined by the site physician
clinically significant abnormal screening labs, as determined by the site physician 8. Participants with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the 6 months prior to screening or participants who represent a significant risk of suicide in the opinion of the investigator. 9. Presence or positive history of neurological illness, including seizures, mental retardation or any other disease/procedure/accident/intervention associated with significant injury to or malfunction of the central nervous system (CNS), or history of significant head injury. 10. Any material in the body that is a contraindication for MRI procedures 11. Currently taking any psychotropic medication, including antidepressant medications, benzodiazepines, antipsychotic medications, mood stabilizers, anti-epileptic medications, and stimulants. We will exclude any participant who requires treatment with any psychotropic medication from one of these classes.

What this trial measures

  • Final PharmacoBOLD signals in pre-specified ROIsBaseline and Day 4

    Changes in ketamine-induced PharmacoBOLD fMRI signals in pre-specified ROIs (anterior cingulate cortex) following administrations of TS-134

  • Brief Psychiatric Rating Scale (BPRS)Baseline and Day 4

    Changes in BPRS scores following administrations of TS-134