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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT03141658

Run by

Taisho Pharmaceutical R&D Inc.

People needed

63

Starts

2017-06-28

Expected to finish

2018-04-10

Last updated by the study team

2018-04-30

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• New York State Psychiatric Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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