Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-03 @ 1:01 AM
Study NCT ID:
NCT02151656
Status:
COMPLETED
Last Update Posted:
2016-12-16
First Post:
2014-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
F17464 in Acute Schizophrenia Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000717801', 'term': 'dopamine D3 receptor antagonist F17464'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-15', 'studyFirstSubmitDate': '2014-05-28', 'studyFirstSubmitQcDate': '2014-05-29', 'lastUpdatePostDateStruct': {'date': '2016-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of the Positive and Negative Syndrome Scale (PANSS) total score', 'timeFrame': 'Day 43', 'description': 'Change from baseline to Day 43 of the PANSS total score'}]}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Mental disorders', 'Antipsychotic Drugs'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the potential efficacy of oral F17464 in comparison to placebo over 6 weeks in patients with acute exacerbation of schizophrenia. Study design: double-blind, randomized, placebo-controlled, parallel-groups, fixed-dose design, multicentre study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDemographic and other characteristics\n\n* Male or female, 18-64 years of age inclusive\n* primary diagnosis of schizophrenia undergoing an acute exacerbation with prominent "active phase" symptoms, as described by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition - Text Revision (DSM IV-TR) using the MINI 6.0 (Mini-International Neuropsychiatric Interview) for schizophrenia and psychotic disorders related to DSM IV-TR\n* Well-documented diagnosis of schizophrenia for a minimum of 1 year before the screening visit\n* Since the diagnosis of schizophrenia, the average number of hospitalisations should be no higher than 2 per year (the minimum duration of hospitalization should be more than 4 days)\n* During the year before Visit 1, maximum 3 acute psychotic episodes that required hospitalization or change of antipsychotic medication or other therapeutic intervention\n* Adequate clinical response to well-conducted treatment courses during previous acute episodes. A well conducted treatment course is defined as an antipsychotic treatment with the usual doses for at least 4 weeks\n\nCurrent acute episode\n\n* Structured Clinical Interview for the Positive And Negative Syndrome Scale (SCI-PANSS) with a PANSS total score ≥ 70 to \\< 120 (at Visit 1 and 2)\n* Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms: delusions, hallucinatory behaviour, conceptual disorganization, suspiciousness/persecution\n* Clinical Global Impression of Severity (CGI-S) score ≥ 4 (moderate or severe)\n* Antipsychotic initiated for this acute episode and/or ongoing chronic antipsychotic treatment, with a maximum of 2 antipsychotics in total needed to be changed (due to inefficacy or safety reasons)\n* Hospitalization and/ or treatment for the current psychotic episode for less than 2 weeks prior to Visit 1\n* No significant improvement of PANSS total score between enrolment (Visit 1) and inclusion (Visit 2) corresponding to a score improvement \\< 20% on positive symptoms subscale\n\nExclusion Criteria:\n\nRelated to the pathology\n\n* Patients in their first acute episode of psychosis\n* Current schizophrenic episode with predominant negative symptoms\n* Patient " known to be refractory " defined as lack of significant improvement (no significant relief of symptoms, and no period of good function) despite adequate courses with at least 3 different antipsychotics medication cycles of an adequate duration (at least 4 weeks) and at adequate dosage during the previous 5 years;\n* Schizoaffective disorder, schizophreniform disorder and other psychotic disorders;\n* Bipolar I and II disorder\n* Pervasive developmental disorder, mental retardation, delirium, dementia, memory impairment and other cognitive disorders that would compromise a reliable assessment according to the investigator\'s opinion\n* Known or suspected borderline or antisocial personality disorder or other DSM IV axis II disorder of sufficient severity to interfere with participation in this study\n* History of tardive dyskinesia or chronic extra-pyramidal symptoms (EPS), serotonin syndrome or neuroleptic malignant syndrome\n* Major depressive disorder which requires a pharmacological treatment\n* At imminent risk of injuring him/herself or others or causing significant damage to property, as judged by the investigator\n* Suicidal risk based on the Columbia-Suicide Severity Rating Scale (C-SSRS)\n\n * Any suicidal behavior in the past year\n * Suicidal ideation of type 4 or 5 in the past month\n\nRelated to treatments\n\n* Structured psychotherapy (e.g. cognitive behavioural therapy) started within 6 weeks before visit 1\n* Electroconvulsive therapy within 3 months before Visit 1\n* Previous lack of response to electroconvulsive therapy\n* Treatment ongoing with a depot neuroleptic (even if less than 1 cycle in duration before Visit 1)\n* Patient having previous treatment course with clozapine within the 4 months prior to Visit 1\n* Requirement of concomitant treatment with any of the prohibited medications\n* History of intolerance or hypersensitivity to other drugs of the same chemical class as F17464 or to rescue medications or any history of severe drug allergy or hypersensitivity'}, 'identificationModule': {'nctId': 'NCT02151656', 'acronym': 'FAST', 'briefTitle': 'F17464 in Acute Schizophrenia Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pierre Fabre Medicament'}, 'officialTitle': 'Effects of F17464 in Acute Exacerbation of Schizophrenia', 'orgStudyIdInfo': {'id': 'F17464 GE 2 01'}, 'secondaryIdInfos': [{'id': '2013-005451-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'F17464', 'description': 'Oral administration - During 6 weeks - 4 capsules daily', 'interventionNames': ['Drug: F17464']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral administration - During 6 weeks - 4 capsules daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'F17464', 'type': 'DRUG', 'armGroupLabels': ['F17464']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nîmes', 'country': 'France', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Sotteville-lès-Rouen', 'country': 'France', 'geoPoint': {'lat': 49.40972, 'lon': 1.09005}}, {'city': 'Balassagyarmat', 'country': 'Hungary', 'geoPoint': {'lat': 48.07296, 'lon': 19.29614}}, {'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Gyula', 'country': 'Hungary', 'geoPoint': {'lat': 46.65, 'lon': 21.28333}}, {'city': 'Daugavpils', 'country': 'Latvia', 'geoPoint': {'lat': 55.88333, 'lon': 26.53333}}, {'city': 'Jelgava', 'country': 'Latvia', 'geoPoint': {'lat': 56.65, 'lon': 23.71278}}, {'city': 'Liepāja', 'country': 'Latvia', 'geoPoint': {'lat': 56.50474, 'lon': 21.01085}}, {'city': 'Strenči', 'country': 'Latvia', 'geoPoint': {'lat': 57.62574, 'lon': 25.68535}}, {'city': 'Arad', 'country': 'Romania', 'geoPoint': {'lat': 46.18333, 'lon': 21.31667}}, {'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Campulum G Muscel', 'country': 'Romania'}, {'city': 'Craiova', 'country': 'Romania', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'city': 'Galati', 'country': 'Romania', 'geoPoint': {'lat': 45.43687, 'lon': 28.05028}}, {'city': 'Iași', 'country': 'Romania', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'city': 'Sibiu', 'country': 'Romania', 'geoPoint': {'lat': 45.8, 'lon': 24.15}}, {'city': 'Târgovişte', 'country': 'Romania', 'geoPoint': {'lat': 44.92543, 'lon': 25.4567}}, {'city': 'Târgu Mureş', 'country': 'Romania', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}, {'city': 'Timișoara', 'country': 'Romania', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'city': 'Arkhangelsky District', 'country': 'Russia'}, {'city': "Engel's", 'country': 'Russia', 'geoPoint': {'lat': 51.48389, 'lon': 46.10528}}, {'city': "Kazan'", 'country': 'Russia', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Orenburg', 'country': 'Russia', 'geoPoint': {'lat': 51.76712, 'lon': 55.09883}}, {'city': 'Saratov', 'country': 'Russia', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'city': 'Tomsk', 'country': 'Russia', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}, {'city': 'Yekaterinburg', 'country': 'Russia', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}], 'overallOfficials': [{'name': 'Françoise TONNER, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pierre Fabre Medicament'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierre Fabre Medicament', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}