CompletedPhase 1ketamine
Effects of TS-134 on Ketamine-induced BOLD Signals in Healthy Subjects
Sponsored by Taisho Pharmaceutical R&D Inc.
NCT ID
NCT03141658
Target Enrollment
63 participants
Start Date
2017-06-28
Est. Completion
2018-04-10
About This Study
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 Studied
Interventions
- •TS-134
- •TS-134
- •Placebo
- •Ketamine
Eligibility
Age:18 Years - 55 Years
Healthy Volunteers:Yes
View full eligibility criteria
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 Locations (1)
New York State Psychiatric Institute
New York, New York, United States