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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE May 3, 2017
First Posted Date  ICMJE May 5, 2017
Last Update Posted Date April 30, 2018
Actual Study Start Date  ICMJE June 28, 2017
Actual Primary Completion Date April 4, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
  • 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
  • Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Screening and Day 6 ]
    Changes in BPRS scores following administrations of TS-134
  • Clinician Administered Dissociative State Scale (CADSS) [ Time Frame: Screening and Day 6 ]
    Changes in CADSS scores following administrations of TS-134
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of TS-134 on Ketamine-induced BOLD Signals in Healthy Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: TS-134
    Multiple dose titrations from 10 mg to 20 mg once daily for 6 days
  • Drug: TS-134
    Multiple dose titrations from 10 mg to 60 mg once daily for 6 days
  • 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
Study Arms  ICMJE
  • Experimental: TS-134 20 mg
    Interventions:
    • Drug: TS-134
    • Other: Ketamine
  • Experimental: TS-134 60 mg
    Interventions:
    • Drug: TS-134
    • Other: Ketamine
  • Experimental: Placebo
    Interventions:
    • Drug: Placebo
    • Other: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2018)
63
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2017)
60
Actual Study Completion Date  ICMJE April 10, 2018
Actual Primary Completion Date April 4, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03141658
Other Study ID Numbers  ICMJE TS134-US103
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Taisho Pharmaceutical R&D Inc.
Study Sponsor  ICMJE Taisho Pharmaceutical R&D Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey A Lieberman, MD New York State Psychiatric Institute
PRS Account Taisho Pharmaceutical R&D Inc.
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP