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Optimization of Treatment and Management of Schizophrenia in Europe WP2 Medication Trial Update

This update provides information on the current status of the medication trial, including study medication, blood levels, training, helpful documents, and getting started.

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Optimization of Treatment and Management of Schizophrenia in Europe WP2 Medication Trial Update

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  1. Large-Scale Integrating Project SEVENTH FRAMEWORK PROGRAMME THEME 1: HEALTH Optimization of Treatment and Management of Schizophrenia in Europe WP2 medication trial

  2. Current status update on: • Study medication • Blood levels • Training days • Helpful documents • Getting started

  3. Study medication Trial medication prepared in two batches: • Batch 1 finished end of March, double-blind capsules only 6 months tenable • Batch 1 send to first 10 centers with full ethical approval • April-May: stability program run on DB capsules • Batch 2 finished in May-June, DB capsules probably tenable for 12 or 18 months

  4. Study medication • Medication send in packages containing: phase I meds for 8 patients and phase II meds for 4 patients • Double blind capsules are fairly large! • We will manage your medication stock • Next week pharmacies of all centers receive dummy kits to test logistics. Please email/ fax letter of receipt to Piramal instantly

  5. Blood levels • End of phase I: blood sample for amisulpride level taken and frozen, send annually to Innsbruck • End of phase II: blood sample for amisulpride/ olanzapine level taken and frozen, send annually to Innsbruck • 4 weeks after the start of phase III: blood sample for clozapine level taken and send directly (ambient) to Innsbruck to adjust dose • If necessary second and third clozapine samples can be send to adjust dose

  6. Training for WP2 • Training focused on PANSS remission criteria • WP2 training combined with WP5 training • Three occasions: March 14 Vienna, March 18 Amsterdam and March 22+23 Amsterdam • Please make sure your team has at least 1 preferably 2 trained raters!

  7. Helpful documents • We have prepared a comprehensive researchers manual (SOP) listing all practical aspects • The OPTiMiSE website contains work sheets that list complete and detailed step-by-step procedures for all visits • The eCRF has automatic queries to correct errors

  8. Getting started • Obtain local and national ethical approval • Have personnel trained • Arrange initiation meeting • Medication kits send to your center • Start including!

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