Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-03-06 @ 5:29 PM
Study NCT ID:
NCT01548612
Status:
COMPLETED
Last Update Posted:
2012-03-08
First Post:
2012-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Add-on Sodium Nitroprusside to Treatment as Usual 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009599', 'term': 'Nitroprusside'}], 'ancestors': [{'id': 'D005292', 'term': 'Ferricyanides'}, {'id': 'D003486', 'term': 'Cyanides'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005290', 'term': 'Ferric Compounds'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D006856', 'term': 'Hydrogen Cyanide'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-07', 'studyFirstSubmitDate': '2012-02-13', 'studyFirstSubmitQcDate': '2012-03-07', 'lastUpdatePostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in BPRS score', 'timeFrame': 'baseline and up to 4 weeks', 'description': 'Brief Psychiatric Rating Scale'}, {'measure': 'Change in PANSS negative subscale score', 'timeFrame': 'Every hour for 4 hours, then at +12h, then daily for 7 days, then weekly for 4 weeks', 'description': 'Positive and Negative Syndrome Scale'}], 'secondaryOutcomes': [{'measure': 'Cognitive assessment', 'timeFrame': 'Baseline and after 12 h', 'description': 'FAS, 2-back, Stroop Color Word Test'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Nitric oxide', 'Sodium nitroprusside'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '23699763', 'type': 'DERIVED', 'citation': 'Hallak JE, Maia-de-Oliveira JP, Abrao J, Evora PR, Zuardi AW, Crippa JA, Belmonte-de-Abreu P, Baker GB, Dursun SM. Rapid improvement of acute schizophrenia symptoms after intravenous sodium nitroprusside: a randomized, double-blind, placebo-controlled trial. JAMA Psychiatry. 2013 Jul;70(7):668-76. doi: 10.1001/jamapsychiatry.2013.1292.'}]}, 'descriptionModule': {'briefSummary': 'In spite of the numerous studies on schizophrenia, its etiology and physiopathology remain unknown. Evidence suggests a possible implication of nitric oxide (NO) in schizophrenia. NO is a gas with unique chemistry and influences the release of neurotransmitters, learning, memory and neurodevelopment. Recent studies that investigated the role of NO in patients with schizophrenia found evidence that points to a disruption in NO-mediated neurotransmission in schizophrenia. Accordingly, we believe that the administration of sodium nitroprusside, an NO donor, will ameliorate schizophrenia symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of schizophrenia\n* Patients in an acute psychotic episode requiring full hospitalization\n\nExclusion Criteria:\n\n* Significant medical conditions (heart, kidney, liver, thyroid or neurological diseases, hypovitaminosis B12, hyponatremia)\n* Pregnancy\n* Breastfeeding\n* Previous hypersensitivity to sodium nitroprusside\n* DSM-IV diagnosis of drug abuse or dependence'}, 'identificationModule': {'nctId': 'NCT01548612', 'briefTitle': 'Add-on Sodium Nitroprusside to Treatment as Usual in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Randomised Double Blind Placebo Controlled Study of Sodium Nitroprusside Added to Treatment as Usual in Patients With Schizophrenia', 'orgStudyIdInfo': {'id': 'SNPSCZ001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sodium nitroprusside', 'interventionNames': ['Drug: Sodium nitroprusside']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Glucose solution 5%', 'interventionNames': ['Drug: Glucose solution']}], 'interventions': [{'name': 'Sodium nitroprusside', 'type': 'DRUG', 'description': 'Intravenous infusion of 0,5 mcg/kg/min for 240 minutes', 'armGroupLabels': ['Sodium nitroprusside']}, {'name': 'Glucose solution', 'type': 'DRUG', 'description': 'Intravenous infusion of glucose solution 5% for 240 minutes', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14048-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'University General Hospital of the Ribeirao Preto Medical School', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'Jaime EC Hallak, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ribeirao Preto Medical School, University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jaime Eduardo Cecilio Hallak', 'investigatorAffiliation': 'University of Sao Paulo'}}}}