Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT00159133
Status:
COMPLETED
Last Update Posted:
2008-01-30
First Post:
2005-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prodrome-Based Early Intervention With Antipsychotics vs. Benzodiazepines 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, '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', 'prodrome based early intervention', 'antipsychotics - benzodiazepine', 'maintenance treatment', 'drug discontinuation'], '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.'}], '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': 'Prodrome based early intervention with an antipsychotic drug vs. benzodiazepine was applied in patients with first episode schizophrenia after one year neuroleptic maintenance treatment. Two groups of patients were followed over a period of 1 year: one further on under maintenance neuroleptic treatment, the other one after stepwise drug discontinuation.', 'detailedDescription': 'In case of early signs of a relapse prodrome based early intervention with an antipsychotic drug (Haloperidol, Risperidone and other) vs. benzodiazepine (Lorazepam) was applied in patients with first episode schizophrenia after one year neuroleptic maintenance treatment. Two groups of patients were followed over a period of 1 year: one further on under maintenance neuroleptic treatment (Haloperidol, Risperidone and other) , the other one after stepwise drug discontinuation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First-episode in schizophrenia (according ICD-10 F20)\n* Age between 18 and 55\n* Informed consent\n* One year neuroleptic maintenance treatment\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': 'NCT00159133', 'briefTitle': 'Prodrome-Based Early Intervention With Antipsychotics vs. Benzodiazepines in First-Episode Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Prodrome-Based Early Intervention With Antipsychotics vs. Benzodiazepine in Patients With First-Episode Schizophrenia After One Year Maintenance Treatment Under Further Maintenance Treatment vs. Stepwise Discontinued Drugs', 'orgStudyIdInfo': {'id': '01GI 9932 - P 2.2.2.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Early intervention with benzodiazepines in case of prodromal symptoms of an impending relapse', 'interventionNames': ['Drug: antipsychotics vs. Lorazepam (Drugs)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Early intervention with antipsychotics in case of prodromal symptoms of an impending relapse', 'interventionNames': ['Drug: antipsychotics vs. Lorazepam (Drugs)']}], 'interventions': [{'name': 'antipsychotics vs. Lorazepam (Drugs)', 'type': 'DRUG', 'description': 'Early intervention with low-dose antipsychotics vs. lorazepam (up to 3 mg/day) in case of early warning signs of an impending relapse;', '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, University of Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstraße 2, 40629 Düsseldorf'}]}, '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'}]}}}