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

NCT03141658 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2018-04-30

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

TS-134

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

DRUG

TS-134

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

DRUG

Placebo

Multiple doses of placebo once daily for 6 days

OTHER

Ketamine

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

Sponsors & Collaborators

  • Taisho Pharmaceutical R&D Inc.

    lead INDUSTRY

Principal Investigators

  • Jeffrey A Lieberman, MD · New York State Psychiatric Institute

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-28
Primary Completion
2018-04-04
Completion
2018-04-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03141658 on ClinicalTrials.gov