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Completed

NCT Number: NCT03141658

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New York State Psychiatric Institute

New York, 10032, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TS-134

Drug

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

Placebo

Drug

Multiple doses of placebo once daily for 6 days

Ketamine

Other

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

Primary outcomes

  1. BOLD fMRI signals in pre-specified ROIs

    Time frame: Screening and Day 6

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

Secondary outcomes

  1. BOLD fMRI signals in whole brain

    Time frame: Screening and Day 6

    Changes in ketamine-induced BOLD fMRI signals in whole brain following administrations of TS-134

  2. Brief Psychiatric Rating Scale (BPRS)

    Time frame: Screening and Day 6

    Changes in BPRS scores following administrations of TS-134

  3. Clinician Administered Dissociative State Scale (CADSS)

    Time frame: Screening and Day 6

    Changes in CADSS scores following administrations of TS-134

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical R&D Inc.

Industry

Registry information

Official study title

A Randomized, Single-blind, Parallel-group Study to Evaluate the Effects of TS-134 on Ketamine-induced BOLD Signals in Resting fMRI in Healthy Adult Subjects

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 5, 2017
Registry last updated
Apr 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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