Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-30 @ 10:47 PM
Study NCT ID:
NCT02567032
Status:
COMPLETED
Last Update Posted:
2020-02-26
First Post:
2015-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adult Study Oxytocin - Behavioral
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}], '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': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 324}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-25', 'studyFirstSubmitDate': '2015-09-29', 'studyFirstSubmitQcDate': '2015-09-30', 'lastUpdatePostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Social Cognition Task Performance', 'timeFrame': 'Through study completion, 2-3 weeks', 'description': 'Participants will undergo computer tasks that measure social cognition. Tasks will involve verbal responses, pressing buttons at specific times, listening, and viewing audio-visual stimuli. Investigators will be measuring the difference in accuracy and verbal content of the responses on the oxytocin day compared to the placebo day.'}], 'secondaryOutcomes': [{'measure': 'Physiological Measurements', 'timeFrame': 'Through study completion, 2-3 weeks', 'description': 'Sensors will be attached to measure heart rate, respiration, and skin conductance during computer tasks.'}, {'measure': 'Questionnaire', 'timeFrame': 'At baseline visit, up to 4 hours', 'description': 'Participants will be asked questions about their current positive and negative symptoms, medical and psychiatric history. Self-report responses will be saved in writing or audio recording.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oxytocin', 'Syntocinon', 'Social Cognition', 'Schizophrenia', 'Psychosis', 'Schizoaffective Disorder', 'Schizophreniform Disorder', 'Psychotic Disorders'], 'conditions': ['Schizophrenia', 'Oxytocin', 'Social Cognition', 'Psychotic Disorders']}, 'descriptionModule': {'briefSummary': "In this study, investigators will examine the behavioral effects and neurophysiological mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset schizophrenia and other psychotic disorders. Such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia and other psychotic disorders.\n\nAim 1: To quantify the effects of exogenous oxytocin on social cognition and behavior in patients with recent-onset schizophrenia.\n\nHypothesis A: Patients and healthy comparison subjects will show enhanced social cognition (e.g., improved interpretation of paralinguistic and emotional cues, such as those involved in emotional or sarcastic communication) after administration of oxytocin versus placebo.\n\nHypothesis B: Patients and healthy comparison subjects will show increased attention to others' eyes and patients will exhibit increased facial affect expressivity after administration of oxytocin versus placebo.", 'detailedDescription': 'Part 2: A supplementary study will be added to the proposed parent study, which includes additional behavioral testing consisting of several social cognition computer tasks, clinical assessments, physiological measurements, and questionnaires. The study will be conducted with the same study arms and study interventions as in the proposed parent study. For this supplementary study, the inclusion criteria has broadened to include patients with bipolar disorder with psychotic features and brief psychotic disorder.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Patients:\n\n* 18 to 45 years of age\n* Clinically stable\n* English Speaking\n* Meet DSM-5 criteria for schizophrenia, schizophreniform, schizoaffective disorder, bipolar disorder with psychotic features, or brief psychotic disorder\n* No or at most only minor changes to medications in the past week\n* Able to use nasal spray\n* Must be capable of providing informed consent\n\nInclusion Criteria for healthy volunteers:\n\n* 18 to 45 years of age\n* Clinically stable\n* English Speaking\n* No diagnosis of mental disorder according to DSM-5, not including mild alcohol use disorder or mild cannabis use disorder\n* Able to use nasal spray\n* Must be capable of providing informed consent\n\nExclusion Criteria for Patients:\n\n* Active substance and alcohol use disorder in the past month as determined by the DSM-5 criteria, not including cannabis use disorder\n* Subjects with atrophic rhinitis, recurrent nose bleeds, severe brain trauma, and cranial-surgical procedures (hypophysectomy)\n* Medical conditions like congestion or sinus problems that could interfere with the study as per the opinion of the investigator\n* Hearing deficits\n* Pregnancy\n* Severe brain trauma\n\nExclusion Criteria for Healthy Controls:\n\n* Active substance and moderate/severe alcohol use disorder, or mood disorder in the past month as determined by the DSM-5 criteria, not including mild alcohol use disorder or mild cannabis use disorder\n* Meet for a current psychiatric disorder according to DSM-5 criteria\n* Subjects with atrophic rhinitis, recurrent nose bleeds, severe brain trauma, and cranial-surgical procedures (hypophysectomy)\n* Medical conditions like congestion or sinus problems that could interfere with the study as per the opinion of the investigator\n* Hearing deficits\n* Pregnancy\n* Severe brain trauma'}, 'identificationModule': {'nctId': 'NCT02567032', 'acronym': 'ASO-Behavioral', 'briefTitle': 'Adult Study Oxytocin - Behavioral', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Mechanisms and Effects of Oxytocin on Social Cognition in Schizophrenia - Behavioral', 'orgStudyIdInfo': {'id': '10-02262'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxytocin', 'description': '40 IU Oxytocin', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline Nasal Spray', 'description': 'Placebo Comparator', 'interventionNames': ['Drug: Saline Nasal Spray']}], 'interventions': [{'name': 'Oxytocin', 'type': 'DRUG', 'otherNames': ['Syntocinon'], 'description': '40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.', 'armGroupLabels': ['Oxytocin']}, {'name': 'Saline Nasal Spray', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': '40 IU of the saline nasal spray will be administered once at the beginning of the visit.', 'armGroupLabels': ['Saline Nasal Spray']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco Veterans Affairs Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Josh D Woolley, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California San Francisco, San Francisco Veterans Affairs Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'San Francisco Veterans Affairs Medical Center', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Joshua Woolley', 'investigatorAffiliation': 'University of California, San Francisco'}}}}