Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-03 @ 7:54 AM
Study NCT ID:
NCT01804920
Status:
UNKNOWN
Last Update Posted:
2018-10-11
First Post:
2013-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
D-Serine Treatment For Tardive Dyskinesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D000071057', 'term': 'Tardive Dyskinesia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D004409', 'term': 'Dyskinesia, Drug-Induced'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2013-03-03', 'studyFirstSubmitQcDate': '2013-03-04', 'lastUpdatePostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in AIMS total score', 'timeFrame': 'biweekly during a period of 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Schizophrenia and Schizoaffective Disorder', 'Tardive Dyskinesia']}, 'descriptionModule': {'briefSummary': 'Presently no generally effective treatments for tardive dyskinesia (TD) are available. D-serine is a naturally occurring amino acid that acts in-vivo as positive allosteric modulator at the glycine site associated with the glutamatergic NMDA receptor. Previous studies have suggested that D-serine may improve motor symptoms, including dyskinesias, which are caused by treatment with presently used antipsychotics drugs.\n\nThe hypothesis under investigation in the present study is that D-serine adjuvant treatment may improve TD in schizophrenia patients diagnosed with this disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age 18-70;\n2. diagnosis of schizophrenia/schizoaffective disorder according to DSM-IV criteria; diagnosis will be made on the basis of SCID interview and information from medical records, previous treating psychiatrists, and family informants;\n3. history of ≥3 months antipsychotic drugs treatment and present stable dose antipsychotic treatment for at last 4 weeks;\n4. fulfillment of Schooler-Kane TD research criteria on a first evaluation performed 2-12 weeks prior to study entrance and on a subsequent evaluation performed prior to allocation to experimental treatment.\n\nExclusion Criteria:\n\n1. meeting criteria for other DSM-IV Axis I diagnoses;\n2. presence of a neurological disorder or history of significant head injury;\n3. substance abuse or alcoholism during entire lifetime;\n4. are judged clinically to be at suicidal or homicidal risk;\n5. female patients who are pregnant or lactating; female patients who are not pregnant or lactating, if sexually active, must be using medically accepted means of contraception.'}, 'identificationModule': {'nctId': 'NCT01804920', 'briefTitle': 'D-Serine Treatment For Tardive Dyskinesia', 'organization': {'class': 'OTHER', 'fullName': 'Herzog Hospital'}, 'officialTitle': 'D-SERINE TREATMENT FOR TARDIVE DYSKINESIA', 'orgStudyIdInfo': {'id': '1600'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'D-serine adjuvant treatment', 'description': 'Random assignment, parallel group, double blind, placebo controlled 8 weeks trial.\n\nFirst arm: D-serine adjuvant treatment, up to 4 g/day Second arm: Placebo adjuvant treatment', 'interventionNames': ['Dietary Supplement: D-serine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo adjuvant treatment', 'description': 'Random assignment, parallel group, double blind, placebo controlled 8 weeks trial.\n\nFirst arm: D-serine adjuvant treatment, up to 4 g/day Second arm: Placebo adjuvant treatment', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'D-serine', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['D-serine adjuvant treatment']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo adjuvant treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Herzog Hospital', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Uriel Heresco-Levy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herzog Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herzog Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director - Psychiatry Department', 'investigatorFullName': 'Heresco-Levi Uriel', 'investigatorAffiliation': 'Herzog Hospital'}}}}