Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT00159120
Status:
COMPLETED
Last Update Posted:
2008-01-30
First Post:
2005-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Maintenance Treatment vs. Stepwise Drug Discontinuation in First-Episode Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-28', 'studyFirstSubmitDate': '2005-09-07', 'studyFirstSubmitQcDate': '2005-09-07', 'lastUpdatePostDateStruct': {'date': '2008-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'relapse rate', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'psychopathology', 'timeFrame': '1 year'}, {'measure': 'social and cognitive functioning', 'timeFrame': '1 year'}, {'measure': 'side-effects', 'timeFrame': '1 year'}, {'measure': 'drop-out', 'timeFrame': '1 year'}, {'measure': 'quality of life', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Schizophrenia', 'first episode', 'neuroleptic maintenance treatment', 'drug discontinuation', 'prodrome based early intervention'], 'conditions': ['Schizophrenia', 'Psychoses']}, 'referencesModule': {'references': [{'pmid': '15146342', 'type': 'BACKGROUND', 'citation': 'Gaebel W, Moller HJ, Buchkremer G, Ohmann C, Riesbeck M, Wolwer W, Von Wilmsdorff M, Bottlender R, Klingberg S. Pharmacological long-term treatment strategies in first episode schizophrenia--study design and preliminary results of an ongoing RCT within the German Research Network on Schizophrenia. Eur Arch Psychiatry Clin Neurosci. 2004 Apr;254(2):129-40. doi: 10.1007/s00406-004-0509-y.'}, {'pmid': '22926606', 'type': 'DERIVED', 'citation': 'Seemuller F, Schennach R, Mayr A, Musil R, Jager M, Maier W, Klingenberg S, Heuser I, Klosterkotter J, Gastpar M, Schmitt A, Schlosser R, Schneider F, Ohmann C, Lewitzka U, Gaebel W, Moller HJ, Riedel M; German Study Group on First-Episode Schizophrenia. Akathisia and suicidal ideation in first-episode schizophrenia. J Clin Psychopharmacol. 2012 Oct;32(5):694-8. doi: 10.1097/JCP.0b013e3182677958.'}, {'pmid': '20673559', 'type': 'DERIVED', 'citation': 'Gaebel W, Riesbeck M, Wolwer W, Klimke A, Eickhoff M, von Wilmsdorff M, Lemke M, Heuser I, Maier W, Huff W, Schmitt A, Sauer H, Riedel M, Klingberg S, Kopcke W, Ohmann C, Moller HJ; German Study Group on First-Episode Schizophrenia. Relapse prevention in first-episode schizophrenia--maintenance vs intermittent drug treatment with prodrome-based early intervention: results of a randomized controlled trial within the German Research Network on Schizophrenia. J Clin Psychiatry. 2011 Feb;72(2):205-18. doi: 10.4088/JCP.09m05459yel. Epub 2010 Jun 29.'}], 'seeAlsoLinks': [{'url': 'http://www.kompetenznetz-schizophrenie.de', 'label': 'Click here for more information about this study: Pharmacological long-term treatment strategies for relapse prevention in first episode schizophrenia'}]}, 'descriptionModule': {'briefSummary': 'After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions prodrome based early intervention take place.', 'detailedDescription': 'After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions pharmacologic early intervention strategies in case of early sign of relapse will be applied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients after 1 year of maintenance treatment after their first-episode in schizophrenia (according ICD-10 F20)\n* Age between 18 and 55\n* Informed consent\n* One year neuroleptic maintenance treatment\n* Reaching stable course\n\nExclusion Criteria:\n\n* Residence outside of the catchment area\n* Legal reasons\n* Insufficient knowledge of the german language\n* Substance abuse or addiction\n* Pregnancy\n* Serious physical illness\n* Organic brain disease\n* Contraindication to neuroleptic treatment'}, 'identificationModule': {'nctId': 'NCT00159120', 'briefTitle': 'Maintenance Treatment vs. Stepwise Drug Discontinuation in First-Episode Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Maintenance Treatment vs. Stepwise Drug Discontinuation After One Year of Maintenance Treatment in First-Episode Schizophrenia', 'orgStudyIdInfo': {'id': '01GI 9932 - P 2.2.2.1 / 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'further maintenance antipsychotic treatment and prodrome-based early intervention', 'interventionNames': ['Other: maintained antipsychotic treatment vs. stepwise drug discontinuation']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'stepwise drug discontinuation (after 1 year maintenance antipsychotic treatment) and prodrome-based early intervention', 'interventionNames': ['Other: maintained antipsychotic treatment vs. stepwise drug discontinuation']}], 'interventions': [{'name': 'maintained antipsychotic treatment vs. stepwise drug discontinuation', 'type': 'OTHER', 'description': 'maintained antipsychotic treatment (in low dose) vs. stepwise drug discontinuation; both supplemented by prodrome-based early intervention; 1 year', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40629', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'German Research Network on Schizophrenia, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Wolfgang Gaebel, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University of Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}, {'name': 'German Research Network On Schizophrenia', 'class': 'NETWORK'}, {'name': 'Janssen-Cilag Ltd.', 'class': 'INDUSTRY'}, {'name': 'University of Bonn', 'class': 'OTHER'}, {'name': 'Humboldt-Universität zu Berlin', 'class': 'OTHER'}, {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, {'name': 'University of Göttingen', 'class': 'OTHER'}, {'name': 'University of Cologne', 'class': 'OTHER'}, {'name': 'Mainz University', 'class': 'OTHER'}, {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, {'name': 'Universität Duisburg-Essen', 'class': 'OTHER'}, {'name': 'University of Mannheim', 'class': 'OTHER'}, {'name': 'University of Jena', 'class': 'OTHER'}, {'name': 'Martin-Luther-Universität Halle-Wittenberg', 'class': 'OTHER'}, {'name': 'RWTH Aachen University', 'class': 'OTHER'}, {'name': 'University of Wuerzburg', 'class': 'OTHER'}]}}}