Effects of TS-134 on Ketamine-induced BOLD Signals in Healthy Subjects
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
1 other identifier
interventional
63
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Jun 2017
Typical duration for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2017
CompletedFirst Posted
Study publicly available on registry
May 5, 2017
CompletedStudy Start
First participant enrolled
June 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2018
CompletedApril 30, 2018
April 1, 2018
9 months
May 3, 2017
April 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BOLD fMRI signals in pre-specified ROIs
Changes in ketamine-induced BOLD fMRI signals in pre-specified ROIs (anterior cingulate cortex (ACC) and anterior insula) following administrations of TS-134
Screening and Day 6
Secondary Outcomes (3)
BOLD fMRI signals in whole brain
Screening and Day 6
Brief Psychiatric Rating Scale (BPRS)
Screening and Day 6
Clinician Administered Dissociative State Scale (CADSS)
Screening and Day 6
Study Arms (3)
TS-134 20 mg
EXPERIMENTALTS-134 60 mg
EXPERIMENTALPlacebo
EXPERIMENTALInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York State Psychiatric Institute
New York, New York, 10032, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey A Lieberman, MD
New York State Psychiatric Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2017
First Posted
May 5, 2017
Study Start
June 28, 2017
Primary Completion
April 4, 2018
Study Completion
April 10, 2018
Last Updated
April 30, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share