Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT01234558
Status:
COMPLETED
Last Update Posted:
2012-09-12
First Post:
2010-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single IV Dose of GLYX-13 in Patients With Treatment-Resistant Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-10-11', 'releaseDate': '2014-10-09'}, {'resetDate': '2015-08-11', 'releaseDate': '2015-07-17'}], 'estimatedResultsFirstSubmitDate': '2014-10-09'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C507283', 'term': 'GLYX-13 peptide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-10', 'studyFirstSubmitDate': '2010-11-03', 'studyFirstSubmitQcDate': '2010-11-03', 'lastUpdatePostDateStruct': {'date': '2012-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in depression score', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'Change in BPRS+', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['depression', 'NMDA antagonist', 'treatment resistant'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '25782764', 'type': 'DERIVED', 'citation': 'Preskorn S, Macaluso M, Mehra DO, Zammit G, Moskal JR, Burch RM; GLYX-13 Clinical Study Group. Randomized proof of concept trial of GLYX-13, an N-methyl-D-aspartate receptor glycine site partial agonist, in major depressive disorder nonresponsive to a previous antidepressant agent. J Psychiatr Pract. 2015 Mar;21(2):140-9. doi: 10.1097/01.pra.0000462606.17725.93.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether GLYX-13 reduces depression score in patients with treatment-resistant depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of major depressive disorder consistent with DSM-IV-TR\n* current episode greater than 8 weeks in duration\n* Hamilton Depression score \\>/- 21\n* less than 25% reduction in depression during current episode assessed by ATRQ\n\nExclusion Criteria:\n\n* Axis diagnosis of other psychiatric disorders\n* Experiencing hallucinations, delusions, other psychotic symptomatology\n* ECT during current episode'}, 'identificationModule': {'nctId': 'NCT01234558', 'briefTitle': 'Single IV Dose of GLYX-13 in Patients With Treatment-Resistant Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Naurex, Inc, an affiliate of Allergan plc'}, 'officialTitle': 'Randomized, Double Blind, Placebo Controlled, Single IV Dose Parallel Efficacy and Safety Study of GLYX-13 in Subjects With Inadequate/Partial Response to Antidepressants During the Current Episode of Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'GLYX13-C201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'description': 'IV placebo', 'interventionNames': ['Drug: GLYX-13']}, {'type': 'EXPERIMENTAL', 'label': 'GLYX-13, 1 mg/kg', 'interventionNames': ['Drug: GLYX-13']}, {'type': 'EXPERIMENTAL', 'label': 'GLYX-13, 5 mg/kg', 'interventionNames': ['Drug: GLYX-13']}, {'type': 'EXPERIMENTAL', 'label': 'GLYX-13, 10 mg/kg', 'interventionNames': ['Drug: GLYX-13']}], 'interventions': [{'name': 'GLYX-13', 'type': 'DRUG', 'otherNames': ['ThrProProThr'], 'description': 'single IV dose', 'armGroupLabels': ['GLYX-13, 1 mg/kg', 'GLYX-13, 10 mg/kg', 'GLYX-13, 5 mg/kg', 'Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Mulitple', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}], 'overallOfficials': [{'name': 'Ronald M Burch, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Naurex, Inc, an affiliate of Allergan plc'}, {'name': 'Vishaal Mehra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Artemis Clinical Research, San Diego CA'}, {'name': 'Raymond Manning, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CNRI-LA, Pico Rivera CA'}, {'name': 'Paul Gross, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lehigh Center for Clinical Research, Allentown PA'}, {'name': 'Surinder Randhawa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lynn Health Sciences Institute, Oklahoma City OK'}, {'name': 'David Greuner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CRI-WW, Philadelphia PA'}, {'name': 'David Krefetz, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CRI-WW Lordes Hospital, Willingboro NJ'}, {'name': 'Benji Kurian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'U Texas SW Medical Center, Dallas TX'}, {'name': 'Michael Lesem, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Claghorn-Lesem Research Clinic, Houston TX'}, {'name': 'Matthew Macaluso, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Center, Univ Kansas, Wichita KS'}, {'name': 'Stephen Murray, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinilabs, New York, NY'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Naurex, Inc, an affiliate of Allergan plc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-10-09', 'type': 'RELEASE'}, {'date': '2014-10-11', 'type': 'RESET'}, {'date': '2015-07-17', 'type': 'RELEASE'}, {'date': '2015-08-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Naurex, Inc, an affiliate of Allergan plc'}}}}