drugset / Trial / NCT00204061
Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis
Phase 4
Completed
124 enrolled
University of Cologne
Department of Psychiatry University of Bonn · collabGerman Federal Ministry of Education and Research · collabGerman Research Network On Schizophrenia · collabHeinrich-Heine University, Duesseldorf · collabLudwig-Maximilians - University of Munich · collabSanofi-Synthelabo · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2001-01
- Primary completion
- 2005-06
- Completion
- 2005-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amisulpride | Small molecule | 50 mg | — |
| Subject | Amisulpride | Small molecule | 800 mg | — |