Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-28 @ 11:19 PM
Study NCT ID:
NCT04190004
Status:
COMPLETED
Last Update Posted:
2019-12-09
First Post:
2019-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intranasal Vasopressin on Cooperative Behavior 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': 'D014667', 'term': 'Vasopressins'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'After completion of clinical assessments all subjects will receive either 40 IU of vasopressin or saline in counterbalanced order on two separate days and perform the behavioral tasks'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-05', 'studyFirstSubmitDate': '2019-12-03', 'studyFirstSubmitQcDate': '2019-12-05', 'lastUpdatePostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance in Dictator game', 'timeFrame': '60 minutes', 'description': 'Amount of money shared in dictator game'}, {'measure': 'Performance in stag hunt game', 'timeFrame': '60 minutes', 'description': 'Security level in stag hunt game'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The study investigates the effect of 40IU of intranasal vasopressin on cooperative behavior in patients with schizophrenia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-45 years\n* Diagnosed as Schizophrenia or Schizophreniform disorder as per DSM IV TR\n* At least 7 years of formal education\n* MOCA score \\>24\n\nExclusion Criteria:\n\n* Diagnoses of SIADH, Diabetes Insipidus\n* Substance dependence in the past 12 months, excluding nicotine dependence\n* Current comorbid axis 1 psychiatric disorder\n* Hypersensitivity or previous allergy to Vasopressin\n* Serious medical or neurological illness which may interfere with assessment and administration of vasopressin\n* Hypertension\n* Impaired renal functions based on serum creatinine above 1.5\n* Electrolyte imbalance\n* Receiving ECT or has received ECT in the past 8 weeks\n* Clinical history of mental retardation\n* Pregnancy • Lactation\n* Risk of harm to self or others\n* Any significant nasal pathology which may hinder the intranasal absorption of the drug\n* Hearing or visual impairment that significantly affects the comprehension and execution of the study'}, 'identificationModule': {'nctId': 'NCT04190004', 'briefTitle': 'Effect of Intranasal Vasopressin on Cooperative Behavior in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'National Institute of Mental Health and Neuro Sciences, India'}, 'officialTitle': 'Effect of Intranasal Vasopressin on Cooperative Behavior in Schizophrenia', 'orgStudyIdInfo': {'id': 'IEC/2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vasopressin', 'description': 'All subjects will receive bot 40IU of vasopressin and saline placebo in counterbalanced design', 'interventionNames': ['Drug: Vasopressins']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'All subjects will receive bot 40IU of vasopressin and saline placebo in counterbalanced design', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vasopressins', 'type': 'DRUG', 'description': '40 International units of vasopressin or placebo will be given intra-nasally. The order of the administration will be counterbalanced', 'armGroupLabels': ['vasopressin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '40 International units of vasopressin or placebo will be given intra-nasally. The order of the administration will be counterbalanced', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560029', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'National Institute of Mental Health and Neurosciecnes', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Mental Health and Neuro Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Additional Professor', 'investigatorFullName': 'Dr Naren P Rao', 'investigatorAffiliation': 'National Institute of Mental Health and Neuro Sciences, India'}}}}