Schizophrenia Clinical Trial
Official title:
Maintenance Treatment vs. Stepwise Drug Discontinuation After One Year of Maintenance Treatment in First-Episode Schizophrenia
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.
Status | Completed |
Enrollment | 71 |
Est. completion date | June 2006 |
Est. primary completion date | June 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Patients after 1 year of maintenance treatment after their first-episode in schizophrenia (according ICD-10 F20) - Age between 18 and 55 - Informed consent - One year neuroleptic maintenance treatment - Reaching stable course Exclusion Criteria: - Residence outside of the catchment area - Legal reasons - Insufficient knowledge of the german language - Substance abuse or addiction - Pregnancy - Serious physical illness - Organic brain disease - Contraindication to neuroleptic treatment |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | German Research Network on Schizophrenia, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf | Düsseldorf | North Rhine-Westphalia |
Lead Sponsor | Collaborator |
---|---|
Heinrich-Heine University, Duesseldorf | German Federal Ministry of Education and Research, German Research Network On Schizophrenia, Humboldt-Universität zu Berlin, Janssen-Cilag Ltd., Ludwig-Maximilians - University of Munich, Mainz University, Martin-Luther-Universität Halle-Wittenberg, RWTH Aachen University, Universität Duisburg-Essen, University Hospital Tuebingen, University of Bonn, University of Cologne, University of Göttingen, University of Jena, University of Mannheim, University of Wuerzburg |
Germany,
Gaebel W, Möller HJ, Buchkremer G, Ohmann C, Riesbeck M, Wölwer 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | relapse rate | 1 year | No | |
Secondary | psychopathology | 1 year | No | |
Secondary | social and cognitive functioning | 1 year | No | |
Secondary | side-effects | 1 year | Yes | |
Secondary | drop-out | 1 year | No | |
Secondary | quality of life | 1 year | No |
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