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

• Sponsor: Taisho Pharmaceutical R&D Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03141658
• Collaborator: (none)
• Enrollment: 63
• Location: 1
• Arms: 3
• Actual Duration (Months): 9.4
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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: TS-134; Drug: Placebo; Other: Ketamine	Phase 1

Study Design

• Study Type: Interventional
• 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: Jun 28, 2017
• Actual Primary Completion Date: Apr 4, 2018
• Actual Study Completion Date: Apr 10, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. BOLD fMRI signals in pre-specified ROIs [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 [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) [Screening and Day 6]

   Changes in BPRS scores following administrations of TS-134

3. Clinician Administered Dissociative State Scale (CADSS) [Screening and Day 6]

   Changes in CADSS scores following administrations of TS-134

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taisho Pharmaceutical R&D Inc.
• ClinicalTrials.gov Identifier: NCT03141658
• Other Study ID Numbers: TS134-US103
• First Posted: May 5, 2017
• Last Update Posted: Apr 30, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

No Results Posted as of Apr 30, 2018