Workpackage 03

Workpackage Objectives

• To receive and collate the latest CIAS-relevant data from industry and academia, and convene an international meeting of academics, industry and regulators to begin a cross-party discussion about optimal clinical trial designs to study CIAS in Europe (Task 1).
• To validate against MCCB and a functional outcome (UPSA2) in patients with schizophrenia two computerised cognitive batteries (Cogstate, CANTAB), including practice effects.
• To assess sensitivity to relevant cognitive change of these batteries pre- and post single-dose challenge with d-amphetamine.
• To validate MCCB and UPSA2 in two non-English speaking formats in different cultural settings in Spain and Germany.
• To test the concept that combining cognitive enhancement with cognitive training leads to additive and/or synergistic effects.
• To compare and evaluate two computerised cognitive remediation platforms as possible companion treatments to be used along with drug development for CIAS interventions.

Workpackage Leads

Academic Lead: Prof. Shôn Lewis, The University of Manchester, UK
EFPIA Lead: Dr. Judith Jaeger, AstraZeneca AB, Sweden

Workpackage Partners

• H. Lundbeck A/S
• King’s College London
• The University of Manchester 
• AstraZeneca AB
• Janssen Pharmaceutica NV
• Novartis Pharma AG
• Pfizer Limited
• Abbott Laboratories

Synergy between academia and industry

Pfizer will make in-kind contribution in terms of an opinion-leaders conference on the topic area of CIAS in the first 3 months of the WP: Palumbo and Badura, and Jaeger (Astra Zeneca), Drake (Manchester), Wykes (KCL) and Arango and Meyer-Lindenberg have expertise in CIAS. Lewis has expertise in outcomes research and project management. Lopez-Lopez (Novartis) will contribute in-kind through clinical data from a European development trial on a new CIAS compound to be run from March 10 through Jan 2011. Kapur and Panayiota (KCL) have expertise in basic and clinical psychopharmacology. Wykes (KCL), Drake (Manchester) and Venkatesha Murthy (GSK) have expertise in computerised CRT. The WP will receive added value from the infrastructure support available through the government-funded mental health research networks in the UK, Spain and Germany. Facilitation and performance management for externally-funded multisite studies, commercial and non-commercial, is a core function of each network. The UK MHRN (www.mhrn.info) is a network of eight clinical-academic centres set up in 2004 to provide recruitment and follow-up platforms for multisite studies. It provides fully-funded research assistants to undertake patient eligibility screening. The network is jointly coordinated by Manchester (Lewis) and by KCL (Wykes). Collaboration with industry is one of the MHRN’s key objectives. The Spanish multisite network was set up in 2006 and receives substantial central funding, with 5 disease-based programmes, one in schizophrenia. The director is Dr. Celso Arango (Madrid). The German schizophrenia network is run by Prof. Meyer-Lindenberg (CIMH).