Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-04-04 @ 2:01 AM
Study NCT ID:
NCT01936051
Status:
COMPLETED
Last Update Posted:
2019-04-08
First Post:
2013-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modeling Between Plasma Concentration and Serotonin Transporter Occupancy Induced by Escitalopram in Obsessive-compulsive Disorder(OCD) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-04', 'studyFirstSubmitDate': '2013-08-27', 'studyFirstSubmitQcDate': '2013-09-02', 'lastUpdatePostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serotonin transporter occupancy', 'timeFrame': '72hr after oral administration of escitalopram'}], 'secondaryOutcomes': [{'measure': 'genotype', 'timeFrame': 'baseline'}, {'measure': 'Yale-Brown Obsessive Compulsive Scale(Y-BOCS) Score', 'timeFrame': 'baseline', 'description': 'scale for the severity of Obsessive-compulsive symptoms'}, {'measure': 'serotonin transporter occupancy', 'timeFrame': 'within the first 24hrs after oral administration of escitalopram', 'description': 'serotonin transporter occupancy measured at 5 hour and 24 hour after oral dose of escitalopram'}, {'measure': 'escitalopram plasma concentration', 'timeFrame': 'within 72 hours after oral administration of escitalopram', 'description': 'plasma concentration of escitalopram at baseline, 1, 2, 3, 5, 8, 10, 24, 48, 72 hour after oral dose of escitalopram'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['OCD']}, 'descriptionModule': {'briefSummary': 'To modeling the pharmacokinetic-pharmacodynamic(PK-PD) simulation with the plasma concentration and the transporter occupancy from OCD patients treated with escitalopram.\n\nTo examine the effect of G2677T/A single nucleotide polymorphism(SNP) of ABCB1 gene to the PK-PD modeling in OCD patients treated with escitalopram.', 'detailedDescription': 'To measure plasma concentration of escitalopram in OCD patients treated with escitalopram.\n\nTo measure serotonin transporter occupancy by escitalopram in OCD patients treated with escitalopram.\n\nTo genotype G2677T/A SNP of ABCB1 gene in OCD patients treated with escitalopram.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'OCD patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of OCD based on Diagnostic and Statistical Manual(DSM)-IV criteria\n* no change of escitalopram dosage in 6 weeks\n\nExclusion Criteria:\n\n* psychiatric comorbidity other than OCD\n* History of head injury, epilepsy, other general medical disorder'}, 'identificationModule': {'nctId': 'NCT01936051', 'briefTitle': 'Modeling Between Plasma Concentration and Serotonin Transporter Occupancy Induced by Escitalopram in Obsessive-compulsive Disorder(OCD) Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Modeling Between Plasma Concentration and Serotonin Transporter Occupancy Induced by Escitalopram in Obsessive-compulsive Disorder(OCD) Patients', 'orgStudyIdInfo': {'id': 'H-1109-086-378'}, 'secondaryIdInfos': [{'id': '2011-0931', 'type': 'OTHER', 'domain': 'Seoul National university Hospital IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'OCD patients', 'description': 'OCD patients being treated with any dose of escitalopram'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jun Soo Kwon, M.D, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Modeling Between Plasma Concentration and Serotonin Transporter Occupancy Induced by Escitalopram in OCD Patients', 'investigatorFullName': 'Jun Soo Kwon', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}