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Effects of TS-134 on Ketamine-induced BOLD Signals in Healthy Subjects

NCT ID: NCT03141658

Last Updated: 2018-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-28

Study Completion Date

2018-04-10

Brief Summary

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The purpose of this study is to evaluate the effects of TS-134 on ketamine-induced BOLD signals in ROIs in resting fMRI in healthy adult subjects.

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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TS-134 ketamine fMRI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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TS-134 20 mg

Group Type EXPERIMENTAL

TS-134

Intervention Type DRUG

Multiple dose titrations from 10 mg to 20 mg once daily for 6 days

Ketamine

Intervention Type OTHER

0.23 mg/kg bolus over one minute on Screening (baseline) and Day 6

TS-134 60 mg

Group Type EXPERIMENTAL

TS-134

Intervention Type DRUG

Multiple dose titrations from 10 mg to 60 mg once daily for 6 days

Ketamine

Intervention Type OTHER

0.23 mg/kg bolus over one minute on Screening (baseline) and Day 6

Placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Multiple doses of placebo once daily for 6 days

Ketamine

Intervention Type OTHER

0.23 mg/kg bolus over one minute on Screening (baseline) and Day 6

Interventions

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TS-134

Multiple dose titrations from 10 mg to 20 mg once daily for 6 days

Intervention Type DRUG

TS-134

Multiple dose titrations from 10 mg to 60 mg once daily for 6 days

Intervention Type DRUG

Placebo

Multiple doses of placebo once daily for 6 days

Intervention Type DRUG

Ketamine

0.23 mg/kg bolus over one minute on Screening (baseline) and Day 6

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy adult male and female subjects between 18 and 55 years of age inclusive (at the time of initial informed consent)
* Body weight ≥ 45 and ≤ 87 kg
* Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m2

Exclusion Criteria

* Female subjects who are pregnant, intend to become pregnant, or are breastfeeding
* History or presence of psychiatric or neurologic disease or condition
* History of first-degree relative with schizophrenia or mood disorder with psychosis
* History of alcohol or drug abuse
* History of recreational ketamine use, recreational PCP use, or an adverse reaction to ketamine
* History of violence
* Presence or positive history of significant medical illness, including high blood pressure, low blood pressure or orthostatic hypotension
* Any subjects who show subthreshold ketamine BOLD response
* Metal implants, pacemaker, other metal or paramagnetic objects contained within the body
* Claustrophobia
* Subject with any history of suicidal behavior or is currently at risk of suicide in the opinion of the investigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taisho Pharmaceutical R&D Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey A Lieberman, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

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New York State Psychiatric Institute

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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TS134-US103

Identifier Type: -

Identifier Source: org_study_id