Healthy Volunteers
Conditions
Keywords
TS-134, ketamine, fMRI
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.
Interventions
DRUGTS-134
Multiple dose titrations from 10 mg to 20 mg once daily for 6 days
DRUGPlacebo
Multiple doses of placebo once daily for 6 days
OTHERKetamine
0.23 mg/kg bolus over one minute on Screening (baseline) and Day 6
Sponsors
Taisho Pharmaceutical R&D Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed