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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: TS-134; Drug: Placebo; Other: Ketamine

• Registration Number: NCT03141658
• Lead Sponsor: Taisho Pharmaceutical R&D Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-05
• Study Start: 2017-06-28
• Status Verified: 2018-04
• Primary Completion: 2018-04-04
• Study Completion: 2018-04-10
• Last Update Submitted: 2018-04-27
• Last Update Posted: 2018-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TS-134 60 mg	Ketamine	-
TS-134 20 mg	TS-134	-
TS-134 20 mg	Ketamine	-
TS-134 60 mg	TS-134	-
Placebo	Placebo	-
Placebo	Ketamine	-

Primary Outcome Measures

Name	Time	Method
BOLD fMRI signals in pre-specified ROIs	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 Outcome Measures

Name	Time	Method
BOLD fMRI signals in whole brain	Screening and Day 6	Changes in ketamine-induced BOLD fMRI signals in whole brain following administrations of TS-134
Brief Psychiatric Rating Scale (BPRS)	Screening and Day 6	Changes in BPRS scores following administrations of TS-134
Clinician Administered Dissociative State Scale (CADSS)	Screening and Day 6	Changes in CADSS scores following administrations of TS-134

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States