Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-15 @ 4:06 PM
Study NCT ID:
NCT02220504
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2014-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-13', 'studyFirstSubmitDate': '2014-08-13', 'studyFirstSubmitQcDate': '2014-08-18', 'lastUpdatePostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse rate.', 'timeFrame': 'At 3 years.', 'description': 'The main outcome was the percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance.'}], 'secondaryOutcomes': [{'measure': 'Clinical psychopathology.', 'timeFrame': 'At 3 years.', 'description': 'Clinical psychopathology differences between groups are evaluated by the mean change from the study intake to 3 years for the severity of Clinical Global Impression scale (CGI), Brief Psychiatric Rating Scale expanded version of 24 items (BPRS), Scale for the Assessment of Positive Symptoms (SAPS) and Scale for the Assessment of Negative Symptoms (SANS) total scores.'}, {'measure': 'Time to relapse.', 'timeFrame': 'At 3 years.', 'description': 'Time to relapse in the two groups of patients, discontinuation and maintenance.'}, {'measure': 'Clinical functionality.', 'timeFrame': 'At 3 years.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Treatment', 'Maintenance'], 'conditions': ['Schizophrenia', 'Schizophrenia Relapse', 'Schizophrenia Spectrum and Other Psychotic Disorders']}, 'referencesModule': {'references': [{'pmid': '26759992', 'type': 'DERIVED', 'citation': 'Mayoral-van Son J, de la Foz VO, Martinez-Garcia O, Moreno T, Parrilla-Escobar M, Valdizan EM, Crespo-Facorro B. Clinical outcome after antipsychotic treatment discontinuation in functionally recovered first-episode nonaffective psychosis individuals: a 3-year naturalistic follow-up study. J Clin Psychiatry. 2016 Apr;77(4):492-500. doi: 10.4088/JCP.14m09540.'}]}, 'descriptionModule': {'briefSummary': 'This open-label, non-randomized, prospective study will evaluate the risk of symptoms recurrence during the three years after antipsychotic discontinuation in a sample of functionally recovered first-episode patients with schizophrenia spectrum disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals included in the First Episode Psychosis Clinical Program (PAFIP) at the University Hospital Marqués de Valdecilla (Santander, Spain).\n* A minimum of 18 months on antipsychotic treatment.\n* Meeting clinical remission criteria for at least the 12 months prior to inclusion.\n* Meeting the functional recovery criteria for at least the 6 months prior to inclusion.\n* Stabilized at the lowest effective doses for at least the 3 months prior to inclusion.\n\nExclusion Criteria:\n\n* Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for drug dependence.\n* Meeting DSM-IV criteria for mental retardation.\n* Having a history of neurological disease or head injury.'}, 'identificationModule': {'nctId': 'NCT02220504', 'acronym': 'ADARFEP', 'briefTitle': '3-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Marques de Valdecilla'}, 'officialTitle': 'Clinical Outcome After Antipsychotic Treatment Discontinuation in Functionally Recovered First-episode Non-affective Psychosis Individuals: A 3-year Follow-up', 'orgStudyIdInfo': {'id': 'ADARFEP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Antipsychotic treatment discontinuation (DT)', 'interventionNames': ['Other: Antipsychotic treatment discontinuation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Maintenance antipsychotic treatment (MT)', 'interventionNames': ['Other: Maintenance antipsychotic treatment']}], 'interventions': [{'name': 'Antipsychotic treatment discontinuation', 'type': 'OTHER', 'description': 'Withdrawal of antipsychotic medication to stabilized patients.', 'armGroupLabels': ['Intervention group']}, {'name': 'Maintenance antipsychotic treatment', 'type': 'OTHER', 'description': 'Maintenance antipsychotic medication to stabilized patients.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'facility': 'University Hospital Marques de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}], 'overallOfficials': [{'name': 'Benedicto Crespo-Facorro, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Marqués de Valdecilla, IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, Santander, Spain. CIBERSAM Centro Investigación Biomédica en Red Salud Mental, Madrid, Spain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Marques de Valdecilla', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centro de Investigación Biomédica en Red de Salud Mental', 'class': 'NETWORK'}, {'name': 'Instituto de Investigación Marqués de Valdecilla', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychiatry', 'investigatorFullName': 'Benedicto Crespo-Facorro', 'investigatorAffiliation': 'Fundación Marques de Valdecilla'}}}}