Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-03 @ 3:05 PM
Study NCT ID:
NCT03702933
Status:
UNKNOWN
Last Update Posted:
2018-10-11
First Post:
2018-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
D-serine in Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2018-10-09', 'studyFirstSubmitQcDate': '2018-10-09', 'lastUpdatePostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PANSS Total Score', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'This study will assess the effects of D-serine adjuvant treatment to the ongoing pharmacological treatment of schizophrenia patients that are resistant to treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'schizophrenia patients that do not respond to their treatments', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-5 Schizophrenia criteria, able and willing to give informed consent, and comply to study procedure, adequate contraception, post-menopausal or abstinent, PANSS Total Score equal or greater than 70, score of 4 or greater on two psychotic items\n\nExclusion Criteria:\n\n* clinically significant, uncontrollable or unstable medical condition, mental retardation or severe organic brain syndrome, significant risk of suicide or violent behavior'}, 'identificationModule': {'nctId': 'NCT03702933', 'acronym': 'DSRSZ', 'briefTitle': 'D-serine in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Herzog Hospital'}, 'officialTitle': 'The Effects of Add-On D-serine Pharmacotherapy in Chronic Treatment Resistant Schizophrenia Patients', 'orgStudyIdInfo': {'id': 'HerzogHospital'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Placebo', 'description': 'starch', 'interventionNames': ['Dietary Supplement: D-serine']}, {'label': 'High Dose', 'description': '3.5 g/d D-serine adjuvant treatment', 'interventionNames': ['Dietary Supplement: D-serine']}, {'label': 'Low Dose', 'description': '2.1 g/d D-serine adjuvant treatment', 'interventionNames': ['Dietary Supplement: D-serine']}], 'interventions': [{'name': 'D-serine', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['placebo'], 'description': 'dosage', 'armGroupLabels': ['High Dose', 'Low Dose', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91035', 'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Andrea Durrant, PhD', 'role': 'CONTACT', 'email': 'andy007israel@gmail.com', 'phone': '972527181489'}, {'name': 'Uriel Heresco-Levy, MD', 'role': 'CONTACT', 'email': 'urielh@ekmd.huji.ac.il', 'phone': '97225316906'}], 'facility': 'Herzog Hospital', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'andrea durrant, PhD', 'role': 'CONTACT', 'email': 'andy007israel@gmail.com', 'phone': '972527181489'}, {'name': 'Uriel Heresco-Levy, MD', 'role': 'CONTACT', 'email': 'urielh@ekmd.huji.ac.il', 'phone': '97225316906'}], 'overallOfficials': [{'name': 'Uriel Heresco-Levy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herzog Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herzog Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry', 'investigatorFullName': 'Heresco-Levi Uriel', 'investigatorAffiliation': 'Herzog Hospital'}}}}