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Glutamatergic Mechanisms: Aim2

ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorNew York State Psychiatric Institute

About this trial

In the present study, 120 healthy volunteers (HV) will be randomized to one of three ketamine-induced pharmacoBOLD (phBOLD) arms: low, medium, and high. Within each ketamine arm, participants will be randomized to 4 days of "study drug" \[TS-134 (1st 20 participants) or XT (remaining 100 participants)\] or placebo in a 5:3 ratio (25 study drug:15 placebo per arm).

During the study, each participant will undergo a Screening Period (up to 31 days), a 4-day Treatment Period, and a total of two phBOLD sessions: a first session at Baseline and a second session on Day 4 of the Treatment Period, conducted at least 7 days apart, and a follow up visit.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age between 18-55 at screen

Medically healthy, as assessed by study physician at screen

Capable of understanding the study procedures and able to provide informed consent

Eligible men and women must agree to use a reliable method of birth control (See section 5.3) during the study. Women who are post-menopausal or otherwise not of childbearing potential are also eligible.

Disqualifiers

Current or past Axis I psychiatric history (including Substance Use Disorder/Alcohol Use Disorder, with the exception of nicotine use disorder) as assessed at screen

Positive urine toxicology or alcohol at screen

History of recreational ketamine use, recreational PCP use, or an adverse reaction to ketamine. Participants who have participated in prior research ketamine studies will be eligible. Participants can have infusions not more frequently than biweekly, and not more than 1/month on average, therefore participants entering the study will need to wait one month if they had a single infusion and 6 weeks if they have had two closely spaced infusions.

History of first-degree relative with schizophrenia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ketamine

    Drug

    Ketamine during an MRI

  • Ts-134 or XT

    Drug

    4 days of TS-134 20 mg (1st 20 subjects )or XT (last 100 subjects)

  • Placebo

    Drug

    4 days of placebo

Treatment groups

120 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: High Ketamine, TS-134 (first 20 subjects) or XT (remaining 100 subjects)Experimental treatment 2 interventions
Group B: High ketamine, placeboPlacebo comparator 2 interventions
Group C: Medium Ketamine, TS-134 (first 20 subjects) or XT (remaining 100 subjects)Experimental treatment 2 interventions
Group D: Medium Ketamine, placeboPlacebo comparator 2 interventions
Group E: Low Ketamine, TS-134 (first 20 subjects) or XT (remaining 100 subjects)Experimental treatment 2 interventions
Group F: Low Ketamine, placeboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Final PharmacoBOLD signals in pre-specified ROIs

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

Time frame
Baseline and Day 4
2

Brief Psychiatric Rating Scale (BPRS)

Changes in BPRS scores following administrations of TS-134 or XT

Time frame
Baseline and Day 4

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

New York State Psychiatric Institute

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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