Schizophrenia Clinical Trial
— NeSSyOfficial title:
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
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.
Status | Completed |
Enrollment | 149 |
Est. completion date | March 2014 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Schizophrenia - age 18-65 years - necessity to establish new or change antipsychotic treatment due to unsatisfying results or side effects - written informed consent Exclusion Criteria (amongst others): - Known or suspected hypersensitivity to olanzapine, quetiapine, aripiprazole, flupentixol or haloperidol - Acute suicidal tendency - "Einwilligungsvorbehalt (BGB)" or "Unterbringung (PsychKG)" - Epilepsy - Organic psychosis - Parkinson Disease - Dementia - History of malignant neuroleptic syndrome - QTc interval = 0.5s / history of congenital QTc prolongation |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Universitätsklinikum Aachen | Aachen | |
Germany | Krankenhaus Angermünde | Angermünde | |
Germany | Karl-Jaspers-Klinik | Bad Zwischenahn | |
Germany | Charité - Universitätsmedizin Berlin | Berlin | |
Germany | Vivantes Klinikum Neukölln | Berlin | |
Germany | LWL-Universitätsklinik Bochum der Ruhr-Universität | Bochum | |
Germany | Klinikum Bremen-Ost gGmbH | Bremen | |
Germany | Rheinische Kliniken Düsseldorf der Heinrich-Heine-Universität | Düsseldorf | |
Germany | Städtisches Krankenhaus Eisenhüttenstadt GmbH | Eisenhüttenstadt | |
Germany | Universitätsmedizin Göttingen | Göttingen | |
Germany | Universitätsklinikum Hamburg-Eppendorf | Hamburg | |
Germany | Medizinische Hochschule Hannover | Hannover | |
Germany | Privat-Nerven-Klinik Dr. med. Kurt Fontheim | Liebenburg | |
Germany | Dietrich-Bonhoeffer-Klinik Neubrandenburg | Neubrandenburg | |
Germany | Ruppiner Kliniken | Neuruppin | |
Germany | Ernst von Bergmann Klinikum | Potsdam | |
Germany | Immanuel Klinik Rüdersdorf | Rüdersdorf | |
Germany | Klinik Taufkirchen | Taufkirchen |
Lead Sponsor | Collaborator |
---|---|
University of Bremen | German Federal Ministry of Education and Research |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Contentment with treatment: Patient (SF-36) | 24 weeks | No | |
Primary | Contentment with treatment: Psychiatrist (CGI) | 24 weeks | No | |
Secondary | Subscores of SF-36 | 24 weeks | No | |
Secondary | Subjective wellbeing under neuroleptic treatment scale (SWN-K) | 24 weeks | No | |
Secondary | Positive and Negative Syndrome Scale (PANSS) | 24 weeks | No |
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