drugset / Trial / NCT01248195
Optimization of Treatment and Management of Schizophrenia in Europe
Phase 4
Completed
479 enrolled
Rene Kahn
King's College London · collabLudwig-Maximilians - University of Munich · collabTechnical University of Munich · collabUniversity of Manchester · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of the study is optimising current treatments in schizophrenia and explore novel therapeutic options for schizophrenia. The study intends to both address basic, but so far unanswered, questions in the treatment of schizophrenia and develop new interventions. It is expected that the project will lead to evidence that is directly applicable to treatment guidelines, and will identify potential mechanisms for new drug development.
Timeline
- Start
- 2011-05
- Primary completion
- 2016-04
- Completion
- 2016-04
Publications
- Nasib LG, Winter-van Rossum I, Zuithoff NPA, Boudewijns ZSRM, Leucht S, Kahn RS. Generalizability of the Results of Efficacy Trials in First-Episode Schizophrenia: Comparing Outcome and Study Discontinuation of Groups of Participants in the Optimization of Treatment and Management of Schizophrenia in Europe (OPTiMiSE) Trial. J Clin Psychiatry. 2023 Mar 29;84(3):22m14531. doi: 10.4088/JCP.22m14531.
- Fraguas D, Diaz-Caneja CM, Pina-Camacho L, Winter van Rossum I, Baandrup L, Sommer IE, Glenthoj B, Kahn RS, Leucht S, Arango C. The role of depression in the prediction of a "late" remission in first-episode psychosis: An analysis of the OPTiMiSE study. Schizophr Res. 2021 May;231:100-107. doi: 10.1016/j.schres.2021.03.010. Epub 2021 Apr 7.
- Pollak TA, Vincent A, Iyegbe C, Coutinho E, Jacobson L, Rujescu D, Stone J, Jezequel J, Rogemond V, Jamain S, Groc L, David A, Egerton A, Kahn RS, Honnorat J, Dazzan P, Leboyer M, McGuire P. Relationship Between Serum NMDA Receptor Antibodies and Response to Antipsychotic Treatment in First-Episode Psychosis. Biol Psychiatry. 2021 Jul 1;90(1):9-15. doi: 10.1016/j.biopsych.2020.11.014. Epub 2020 Nov 24.
- Kahn RS, Winter van Rossum I, Leucht S, McGuire P, Lewis SW, Leboyer M, Arango C, Dazzan P, Drake R, Heres S, Diaz-Caneja CM, Rujescu D, Weiser M, Galderisi S, Glenthoj B, Eijkemans MJC, Fleischhacker WW, Kapur S, Sommer IE; OPTiMiSE study group. Amisulpride and olanzapine followed by open-label treatment with clozapine in first-episode schizophrenia and schizophreniform disorder (OPTiMiSE): a three-phase switching study. Lancet Psychiatry. 2018 Oct;5(10):797-807. doi: 10.1016/S2215-0366(18)30252-9. Epub 2018 Aug 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amisulpride | Small molecule | 800 mg | Oral |
| Subject | Clozapine | Other / unclassified | 900 mg | — |
| Comparator | Olanzapine | Small molecule | 20 mg | — |