Large-Scale Integrating ProjectSEVENTH FRAMEWORK PROGRAMME

THEME 1: HEALTH

Optimization of Treatment and Management of Schizophrenia in Europe

WP2 medication trial

Current status update on:

• Study medication• Blood levels• Training days• Helpful documents • Getting started

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

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

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

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!

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

Getting started

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