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

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ClinicalTrials.gov Identifier: NCT03141658
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Taisho Pharmaceutical R&D Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: TS-134 Drug: Placebo Other: Ketamine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : June 28, 2017
Actual Primary Completion Date : April 4, 2018
Actual Study Completion Date : April 10, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: TS-134 20 mg Drug: TS-134
Multiple dose titrations from 10 mg to 20 mg once daily for 6 days

Other: Ketamine
0.23 mg/kg bolus over one minute on Screening (baseline) and Day 6

Experimental: TS-134 60 mg Drug: TS-134
Multiple dose titrations from 10 mg to 60 mg once daily for 6 days

Other: Ketamine
0.23 mg/kg bolus over one minute on Screening (baseline) and Day 6

Experimental: Placebo Drug: Placebo
Multiple doses of placebo once daily for 6 days

Other: Ketamine
0.23 mg/kg bolus over one minute on Screening (baseline) and Day 6




Primary Outcome Measures :
  1. BOLD fMRI signals in pre-specified ROIs [ Time Frame: Screening and Day 6 ]
    Changes in ketamine-induced BOLD fMRI signals in pre-specified ROIs (anterior cingulate cortex (ACC) and anterior insula) following administrations of TS-134


Secondary Outcome Measures :
  1. BOLD fMRI signals in whole brain [ Time Frame: Screening and Day 6 ]
    Changes in ketamine-induced BOLD fMRI signals in whole brain following administrations of TS-134

  2. Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Screening and Day 6 ]
    Changes in BPRS scores following administrations of TS-134

  3. Clinician Administered Dissociative State Scale (CADSS) [ Time Frame: Screening and Day 6 ]
    Changes in CADSS scores following administrations of TS-134



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141658


Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
Taisho Pharmaceutical R&D Inc.
Investigators
Principal Investigator: Jeffrey A Lieberman, MD New York State Psychiatric Institute

Responsible Party: Taisho Pharmaceutical R&D Inc.
ClinicalTrials.gov Identifier: NCT03141658     History of Changes
Other Study ID Numbers: TS134-US103
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Taisho Pharmaceutical R&D Inc.:
TS-134
ketamine
fMRI

Additional relevant MeSH terms:
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action