Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-08 @ 5:38 AM
Study NCT ID:
NCT03040505
Status:
TERMINATED
Last Update Posted:
2023-08-23
First Post:
2017-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Future Mental Projections 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The number of subjects needed was overestimated (from assumptions made in the litterature).', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2019-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-21', 'studyFirstSubmitDate': '2017-01-27', 'studyFirstSubmitQcDate': '2017-01-31', 'lastUpdatePostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of time location strategies', 'timeFrame': '1 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate temporal organization of future thinking in patients with schizophrenia. Patients and control participants will be asked to envision and briefly describe ten personal future events using a cue-words list. Then they will be asked to describe everything that came to their minds (i.e. to think aloud) while they attempted to determine when an event will likely occur. The investigators will compare the proportion of several predefined strategies mentioned by the two groups of participants to locate future events in time. The investigators predict that patients will envision less personal future events and will rely to a lesser extent on strategies to locate events in time, than control participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with Schizophrenia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* for patients only\n* male or female\n* age limits : 18-55 years old\n* under the protection of health insurance\n* who have signed up the consent form\n* schizophrenia or schizo-affective disorder according to the DSM-5 criteria (APA, 2013).\n* clinically stable for at least 2 months\n* patients under guardianship or curatorship need agreement of their legal representative\n* informed of the results of prior medical examination for controls only\n* male or female\n* age limits : 18-55 years old\n* under the protection of health insurance\n* who have sign up the consent form\n* recruited from the general population and matched on gender, age years of schooling\n* no psychiatric history (DSM-5)\n\nExclusion Criteria:\n\n* for both patients and controls\n* current severe or unstable somatic illness\n* neurological history (brain injury \\> 15 minutes loss of consciousness , epilepsia, brain surgery…)\n* current substance use disorder (DSM-5)\n* current major depressive disorder (CDSS,BDI, HDRS)\n* mental retardation (IQ \\< 70, WAIS-4, f-NART)\n* history of general anesthesia 3 months prior to the experiment\n* pregnancy declared by the subject\n* breast feeding\n* current legal control\n* in emergency situation\n* included during exclusion period in another experiment\n* for controls only\n* taking of antipsychotic drugs for the 3 weeks prior to inclusion\n* under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT03040505', 'acronym': 'FutureProSchiz', 'briefTitle': 'Future Mental Projections in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Future Mental Projections in Schizophrenia', 'orgStudyIdInfo': {'id': '6527'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with schizophrenia', 'description': 'Patients with schizophrenia or schizoaffective disorder according to DSM-V criteria', 'interventionNames': ['Other: questionnary']}, {'label': 'Control participants', 'description': '\\- Control participants without psychiatric nor neurological history', 'interventionNames': ['Other: questionnary']}], 'interventions': [{'name': 'questionnary', 'type': 'OTHER', 'description': "Participant's verbalization will be audio recorded and then transcribed by investigators. The investigators will use predefined categories to score the strategies mentioned by participants during the think aloud task.", 'armGroupLabels': ['Control participants', 'Patients with schizophrenia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de psychiatrie 1', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}