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Sponsors and Collaborators: |
University of Cologne German Federal Ministry of Education and Research German Research Network On Schizophrenia Sanofi-Synthelabo Department of Psychiatry University of Bonn Heinrich-Heine University, Duesseldorf Ludwig-Maximilians - University of Munich |
Information provided by: | University of Cologne |
ClinicalTrials.gov Identifier: | NCT00204061 |
The study will provide an empirical basis for a pharmacological treatment option. An open-label, randomized, multi-centre parallel group design is used. An intensified clinical management (CM), which allows needs-based psychological crisis intervention, is compared to a combination of such a CM and the atypical neuroleptic amisulpride. The central hypothesis is that the combination of a clinical management with an atypical neuroleptic is the superior treatment.
Condition | Intervention | Phase |
Schizophrenia Psychoses |
Behavioral: Clinical Management (CM) Drug: Amisulpride |
Phase IV |
MedlinePlus related topics: | Psychotic Disorders Schizophrenia |
ChemIDplus related topics: | Amisulpride Sultopride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Estimated Enrollment: | 130 |
Study Start Date: | January 2001 |
Estimated Study Completion Date: | June 2005 |
The first diagnosis of schizophrenia is preceded by a long lasting period comprising an untreated psychotic and a prodromal state. The duration of untreated psychosis correlates with a significant worsening of several outcome variables and persons fulfilling criteria of a prodromal state are already suffering from prodromal symptoms and from a significant deterioration of social and vocational functioning. However, a sufficient strategy for early intervention is still lacking. The study will provide an empirical basis for a pharmacological treatment option. An open-label, randomized, multi-centre parallel group design is used. An intensified clinical management (CM), which allows needs-based psychological crisis intervention, is compared to a combination of such a CM and the atypical neuroleptic amisulpride. For analysis 130 patients will be recruited within three years, the treatment period is two years.
Ages Eligible for Study: | 14 Years to 36 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
General criteria
Special criteria (present within the last three months prior to the study)
AND / OR
Exclusion Criteria:
Germany, North Rhine-Westphalia | |||||
Department of Psychiatry and Psycotherapy University of Cologne | |||||
Cologne, North Rhine-Westphalia, Germany, 50924 |
University of Cologne |
German Federal Ministry of Education and Research |
German Research Network On Schizophrenia |
Sanofi-Synthelabo |
Department of Psychiatry University of Bonn |
Heinrich-Heine University, Duesseldorf |
Ludwig-Maximilians - University of Munich |
Study Chair: | Joachim Klosterkötter, Professor | Department of Psychiatry and Psycotherapy University of Cologne |
Click here for more information about this study: Early pharmacological and psychological intervention for late prodromal states of psychosis 
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Related Info 
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Study ID Numbers: | 01 GI 9935 - P 1.1.3 |
First Received: | September 12, 2005 |
Last Updated: | September 12, 2005 |
ClinicalTrials.gov Identifier: | NCT00204061 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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