Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT01164059
Status:
COMPLETED
Last Update Posted:
2015-06-22
First Post:
2010-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Effectiveness of Newer Antipsychotics in Comparison With Conventional Antipsychotics 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077152', 'term': 'Olanzapine'}, {'id': 'D005475', 'term': 'Flupenthixol'}, {'id': 'D000069348', 'term': 'Quetiapine Fumarate'}, {'id': 'D000068180', 'term': 'Aripiprazole'}, {'id': 'D006220', 'term': 'Haloperidol'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013892', 'term': 'Thioxanthenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D014966', 'term': 'Xanthenes'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D003987', 'term': 'Dibenzothiazepines'}, {'id': 'D013841', 'term': 'Thiazepines'}, {'id': 'D013846', 'term': 'Thiepins'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D002090', 'term': 'Butyrophenones'}, {'id': 'D007659', 'term': 'Ketones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-19', 'studyFirstSubmitDate': '2010-07-06', 'studyFirstSubmitQcDate': '2010-07-15', 'lastUpdatePostDateStruct': {'date': '2015-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contentment with treatment: Patient (SF-36)', 'timeFrame': '24 weeks'}, {'measure': 'Contentment with treatment: Psychiatrist (CGI)', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Subscores of SF-36', 'timeFrame': '24 weeks'}, {'measure': 'Subjective wellbeing under neuroleptic treatment scale (SWN-K)', 'timeFrame': '24 weeks'}, {'measure': 'Positive and Negative Syndrome Scale (PANSS)', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Schizophrenia', 'atypical antipsychotic drugs', 'conventional antipsychotic drugs', 'olanzapine', 'quetiapine', 'aripiprazole', 'haloperidol', 'flupentixol'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '38958149', 'type': 'DERIVED', 'citation': 'Ibragimov K, Keane GP, Carreno Glaria C, Cheng J, Llosa AE. Haloperidol (oral) versus olanzapine (oral) for people with schizophrenia and schizophrenia-spectrum disorders. Cochrane Database Syst Rev. 2024 Jul 3;7(7):CD013425. doi: 10.1002/14651858.CD013425.pub2.'}, {'pmid': '30981585', 'type': 'DERIVED', 'citation': 'Veselinovic T, Scharpenberg M, Heinze M, Cordes J, Muhlbauer B, Juckel G, Habel U, Ruther E, Timm J, Grunder G; NeSSy Study Group. Disparate effects of first and second generation antipsychotics on cognition in schizophrenia - Findings from the randomized NeSSy trial. Eur Neuropsychopharmacol. 2019 Jun;29(6):720-739. doi: 10.1016/j.euroneuro.2019.03.014. Epub 2019 Apr 10.'}, {'pmid': '27265548', 'type': 'DERIVED', 'citation': 'Grunder G, Heinze M, Cordes J, Muhlbauer B, Juckel G, Schulz C, Ruther E, Timm J; NeSSy Study Group. Effects of first-generation antipsychotics versus second-generation antipsychotics on quality of life in schizophrenia: a double-blind, randomised study. Lancet Psychiatry. 2016 Aug;3(8):717-729. doi: 10.1016/S2215-0366(16)00085-7. Epub 2016 Jun 2.'}, {'pmid': '27016729', 'type': 'DERIVED', 'citation': 'Schulz C, Timm J, Cordes J, Grunder G, Muhlbauer B, Ruther E, Heinze M. Patient-oriented randomisation: A new trial design applied in the Neuroleptic Strategy Study. Clin Trials. 2016 Jun;13(3):251-9. doi: 10.1177/1740774516639910. Epub 2016 Mar 25.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to compare the efficacy and drug tolerability of two strategies for the treatment of schizophrenia. The two strategies consist of utilizing, on the one hand, a conventional antipsychotic like haloperidol or flupentixol and, on the other hand, a newer antipsychotic compound like olanzapine, quetiapine or aripiprazole in patients with schizophrenia.', 'detailedDescription': "There is agreement in the psychiatry community that the so-called atypical antipsychotics should be considered first choice in the treatment of schizophrenic disorders. However, the general superiority of these newer antipsychotic drugs over the older conventional drugs could not be clearly demonstrated in recent controlled clinical trials. The discrepancy between every day's clinical perception and the results of clinical trials raises the question whether the studies performed so far employed the adequate methodological approach to represent the daily practice situation which is characterized by a wide variety of duration and type of the schizophrenic disorder, concomitant diseases, and medications. Moreover, some studies might not have been focused adequately on patient-relevant outcome variables.\n\nThe present study project is designed to answer these open questions. The innovative character of the study design is\n\n1. that different neuroleptic strategies will be compared rather than single antipsychotic drugs, using\n2. an enhanced biometric design, that provides a choice of treatment with respect to the individual patient though the trial as such is randomised controlled and double blind;\n3. that clinically relevant endpoints such as quality of life will be the primary variables, and\n4. inclusion and exclusion criteria lead to a study population representing clinical every day practice as near as possible.\n\nAnother innovatory procedure is that serum levels of the study drugs will be recorded twice during the study. The authors hope that their design might yield transfer effects for other clinical trials facing similar problems."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Schizophrenia\n* age 18-65 years\n* necessity to establish new or change antipsychotic treatment due to unsatisfying results or side effects\n* written informed consent\n\nExclusion Criteria (amongst others):\n\n* Known or suspected hypersensitivity to olanzapine, quetiapine, aripiprazole, flupentixol or haloperidol\n* Acute suicidal tendency\n* "Einwilligungsvorbehalt (BGB)" or "Unterbringung (PsychKG)"\n* Epilepsy\n* Organic psychosis\n* Parkinson Disease\n* Dementia\n* History of malignant neuroleptic syndrome\n* QTc interval ≥ 0.5s / history of congenital QTc prolongation'}, 'identificationModule': {'nctId': 'NCT01164059', 'acronym': 'NeSSy', 'briefTitle': 'Clinical Effectiveness of Newer Antipsychotics in Comparison With Conventional Antipsychotics in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'University of Bremen'}, 'officialTitle': 'Clinical Effectiveness Of The Newer Antipsychotic Compounds Olanzapine, Quetiapine And Aripiprazole In Comparison With Low Dose Conventional Antipsychotics (Haloperidol And Flupentixol) In Patients With Schizophrenia', 'orgStudyIdInfo': {'id': 'NeSSy_200901'}, 'secondaryIdInfos': [{'id': '2009-010966-47', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'atypical antipsychotics', 'description': 'Olanzapine, Quetiapine, or Aripiprazole', 'interventionNames': ['Drug: Olanzapine', 'Drug: Quetiapine', 'Drug: Aripiprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'typical antipsychotics', 'description': 'Haloperidol or Flupentixol', 'interventionNames': ['Drug: Flupentixol', 'Drug: Haloperidol']}], 'interventions': [{'name': 'Olanzapine', 'type': 'DRUG', 'description': 'Olanzapine 10, 15, or 20 mg / day', 'armGroupLabels': ['atypical antipsychotics']}, {'name': 'Flupentixol', 'type': 'DRUG', 'description': 'Flupentixol 6, 9, or 12 mg / day', 'armGroupLabels': ['typical antipsychotics']}, {'name': 'Quetiapine', 'type': 'DRUG', 'description': 'Quetiapine 400, 600, or 800 mg / day', 'armGroupLabels': ['atypical antipsychotics']}, {'name': 'Aripiprazole', 'type': 'DRUG', 'description': 'Aripiprazole 10, 15, or 20 mg / day', 'armGroupLabels': ['atypical antipsychotics']}, {'name': 'Haloperidol', 'type': 'DRUG', 'description': 'Haloperidol 3, 4.5, or 6 mg / day', 'armGroupLabels': ['typical antipsychotics']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aachen', 'country': 'Germany', 'facility': 'Universitätsklinikum Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'city': 'Angermünde', 'country': 'Germany', 'facility': 'Krankenhaus Angermünde', 'geoPoint': {'lat': 53.01499, 'lon': 13.99924}}, {'city': 'Bad Zwischenahn', 'country': 'Germany', 'facility': 'Karl-Jaspers-Klinik', 'geoPoint': {'lat': 53.18475, 'lon': 8.00286}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Vivantes Klinikum Neukölln', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bochum', 'country': 'Germany', 'facility': 'LWL-Universitätsklinik Bochum der Ruhr-Universität', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Bremen', 'country': 'Germany', 'facility': 'Klinikum Bremen-Ost gGmbH', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Rheinische Kliniken Düsseldorf der Heinrich-Heine-Universität', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Eisenhüttenstadt', 'country': 'Germany', 'facility': 'Städtisches Krankenhaus Eisenhüttenstadt GmbH', 'geoPoint': {'lat': 52.15, 'lon': 14.65}}, {'city': 'Göttingen', 'country': 'Germany', 'facility': 'Universitätsmedizin Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Liebenburg', 'country': 'Germany', 'facility': 'Privat-Nerven-Klinik Dr. med. Kurt Fontheim', 'geoPoint': {'lat': 52.02176, 'lon': 10.43169}}, {'city': 'Neubrandenburg', 'country': 'Germany', 'facility': 'Dietrich-Bonhoeffer-Klinik Neubrandenburg', 'geoPoint': {'lat': 53.55735, 'lon': 13.26105}}, {'city': 'Neuruppin', 'country': 'Germany', 'facility': 'Ruppiner Kliniken', 'geoPoint': {'lat': 52.92815, 'lon': 12.80311}}, {'city': 'Potsdam', 'country': 'Germany', 'facility': 'Ernst von Bergmann Klinikum', 'geoPoint': {'lat': 52.39886, 'lon': 13.06566}}, {'city': 'Rüdersdorf', 'country': 'Germany', 'facility': 'Immanuel Klinik Rüdersdorf', 'geoPoint': {'lat': 52.46927, 'lon': 13.78631}}, {'city': 'Taufkirchen', 'country': 'Germany', 'facility': 'Klinik Taufkirchen', 'geoPoint': {'lat': 48.0486, 'lon': 11.61701}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bremen', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Prof. Dr. Eckart Rüther', 'investigatorAffiliation': 'University of Bremen'}}}}