OPTiMiSE

• Research type

  Research Study

• Full title

  Optimization of Treatment and Management of Schizophrenia in Europe

• IRAS ID

  49752

• Contact name

  Philip McGuire

• Sponsor organisation

  University Medical Centre Utrecht

• Eudract number

  2010-020185-19

• ISRCTN Number

  N/A

• Research summary

  When a doctor first prescribes an antipsychotic drug to treat schizophrenia, there is little guidance on some very simple but fundamental questions. For example, which antipsychotic drug should be used first? Can I predict how well the patient will do? If the patient doesn't respond to the first antipsychotic, do I continue for some more time or do I switch to another antipsychotic? If so, which one? This project addresses these questions. It is expected that the project will inform treatment guidelines for schizophrenia, and identify potential mechanisms for new drug development. This five year, multicenter study is funded by the European Commission. In total, 350 first episode schizophrenia patients will be recruited. The specific objectives are: -To provide a rational basis for antipsychotic choices; -To use structural and neurochemical brain scans to optimise treatment outcome and, with blood-based markers, predict treatment response;- To use psychosocial interventions to improve outcome and reduce drug discontinuation. At screening, patients will receive a clinical evaluation and a brain scan (to check for neurological abnormalities and measure the amount of certain chemicals in the brain). Blood samples will be taken for biomarker analyses. All patients will be provided with the antipsychotic drug amisulpride for 4 weeks. Patients who do not show a good response will either continue on amisulpride or switch to olanzapine for 6 weeks. Patients who have still not responded to either drug after this time (10 weeks) will be prescribed clozapine. All patients who respond will be randomized to a psychosocial intervention (twelve weeks) or to treatment as usual. The psychosocial intervention includes psychoeducation, motivational interviewing and SMS warnings to improve medication adherence. The medication that is prescribed during this phase is the choice of the patient and physician. The brain scan and blood markers will be used to predict treatment response.

• REC name

  London - South East Research Ethics Committee

• REC reference

  10/H1102/87

• Date of REC Opinion

  6 Apr 2011

• REC opinion

  Further Information Favourable Opinion