Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-04-21 @ 11:52 PM
Study NCT ID:
NCT03141658
Status:
COMPLETED
Last Update Posted:
2018-04-30
First Post:
2017-05-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of TS-134 on Ketamine-induced BOLD Signals in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-27', 'studyFirstSubmitDate': '2017-05-03', 'studyFirstSubmitQcDate': '2017-05-03', 'lastUpdatePostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BOLD fMRI signals in pre-specified ROIs', 'timeFrame': 'Screening and Day 6', 'description': 'Changes in ketamine-induced BOLD fMRI signals in pre-specified ROIs (anterior cingulate cortex (ACC) and anterior insula) following administrations of TS-134'}], 'secondaryOutcomes': [{'measure': 'BOLD fMRI signals in whole brain', 'timeFrame': 'Screening and Day 6', 'description': 'Changes in ketamine-induced BOLD fMRI signals in whole brain following administrations of TS-134'}, {'measure': 'Brief Psychiatric Rating Scale (BPRS)', 'timeFrame': 'Screening and Day 6', 'description': 'Changes in BPRS scores following administrations of TS-134'}, {'measure': 'Clinician Administered Dissociative State Scale (CADSS)', 'timeFrame': 'Screening and Day 6', 'description': 'Changes in CADSS scores following administrations of TS-134'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TS-134', 'ketamine', 'fMRI'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult male and female subjects between 18 and 55 years of age inclusive (at the time of initial informed consent)\n* Body weight ≥ 45 and ≤ 87 kg\n* Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m2\n\nExclusion Criteria:\n\n* Female subjects who are pregnant, intend to become pregnant, or are breastfeeding\n* History or presence of psychiatric or neurologic disease or condition\n* History of first-degree relative with schizophrenia or mood disorder with psychosis\n* History of alcohol or drug abuse\n* History of recreational ketamine use, recreational PCP use, or an adverse reaction to ketamine\n* History of violence\n* Presence or positive history of significant medical illness, including high blood pressure, low blood pressure or orthostatic hypotension\n* Any subjects who show subthreshold ketamine BOLD response\n* Metal implants, pacemaker, other metal or paramagnetic objects contained within the body\n* Claustrophobia\n* Subject with any history of suicidal behavior or is currently at risk of suicide in the opinion of the investigator'}, 'identificationModule': {'nctId': 'NCT03141658', 'briefTitle': 'Effects of TS-134 on Ketamine-induced BOLD Signals in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taisho Pharmaceutical R&D Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'TS134-US103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TS-134 20 mg', 'interventionNames': ['Drug: TS-134', 'Other: Ketamine']}, {'type': 'EXPERIMENTAL', 'label': 'TS-134 60 mg', 'interventionNames': ['Drug: TS-134', 'Other: Ketamine']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo', 'Other: Ketamine']}], 'interventions': [{'name': 'TS-134', 'type': 'DRUG', 'description': 'Multiple dose titrations from 10 mg to 20 mg once daily for 6 days', 'armGroupLabels': ['TS-134 20 mg']}, {'name': 'TS-134', 'type': 'DRUG', 'description': 'Multiple dose titrations from 10 mg to 60 mg once daily for 6 days', 'armGroupLabels': ['TS-134 60 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Multiple doses of placebo once daily for 6 days', 'armGroupLabels': ['Placebo']}, {'name': 'Ketamine', 'type': 'OTHER', 'description': '0.23 mg/kg bolus over one minute on Screening (baseline) and Day 6', 'armGroupLabels': ['Placebo', 'TS-134 20 mg', 'TS-134 60 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York State Psychiatric Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jeffrey A Lieberman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York State Psychiatric Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taisho Pharmaceutical R&D Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}