Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-02-20 @ 4:46 PM
Study NCT ID:
NCT02535156
Status:
COMPLETED
Last Update Posted:
2017-08-11
First Post:
2015-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Schizotypal Personality Disorder Risperidone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012569', 'term': 'Schizotypal Personality Disorder'}], 'ancestors': [{'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018967', 'term': 'Risperidone'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-10', 'studyFirstSubmitDate': '2015-08-22', 'studyFirstSubmitQcDate': '2015-08-26', 'lastUpdatePostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurophysiological indices of self-monitoring (Error Related Negativity)', 'timeFrame': 'During acute effects of pharmacological treatment (up to 2 hours)', 'description': 'Amplitude of the Error Related Negativity was assessed prior to and 2 hours after treatment administration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizotypal Personality Disorder']}, 'descriptionModule': {'briefSummary': 'Neurophysiological indices of self-monitoring were assessed in a group of patients with Schizotypal Personality Disorder (SPD) and a control group. Both groups were assessed after the administration of risperidone and placebo.', 'detailedDescription': 'The electroencephalogram (EEG) was recorder while participants (SPD participants and controls) performed a behavioral task: the Eriksen Flanker Task. The continuous EEG was segmented, corrected for artifacts and averaged. A component of the event-related brain potential known as the error-related negativity (ERN) was identified and its amplitude quantified in microvolts.\n\nThis procedure was conducted two hours after the administration of risperidone 1 mg and placebo (lactose) on two different experimental days and for each participant group (SPD patients and controls).\n\nThe amplitude of the ERN after placebo was compared between groups to test for baseline (non-drug-induced) differences between patients and controls.\n\nThe impact of risperidone on the amplitude of the ERN was compared between the two participant groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Schizotypal Personality Disorder\n\nExclusion Criteria:\n\n* Major Psychiatric Disorder\n* Medical condition'}, 'identificationModule': {'nctId': 'NCT02535156', 'briefTitle': 'Schizotypal Personality Disorder Risperidone', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'orgStudyIdInfo': {'id': 'CIM/02/112/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Schizotypal Personality Disorder', 'description': 'Schizotypal Personality Disorder (SPD) patients. They received two interventions: risperidone 1 mg and placebo (lactose).', 'interventionNames': ['Drug: Risperidone', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy controls', 'description': 'Control group consisting of healthy volunteers.They received two interventions: risperidone 1 mg and placebo (lactose).', 'interventionNames': ['Drug: Risperidone', 'Drug: Placebo']}], 'interventions': [{'name': 'Risperidone', 'type': 'DRUG', 'description': '1 mg Risperidone', 'armGroupLabels': ['Healthy controls', 'Schizotypal Personality Disorder']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Lactose Placebo', 'armGroupLabels': ['Healthy controls', 'Schizotypal Personality Disorder']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}