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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:5/2/2018
Start Date:June 28, 2017
End Date:April 10, 2018

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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

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.


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
We found this trial at
1
site
1051 Riverside Dr
New York, New York 10032
646-774-5000
Phone: 646-774-8436
New York State Psychiatric Institute The New York State Psychiatric Institute (NYSPI), established in 1895,...
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New York, NY
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