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 |
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.
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
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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