Through multiple clinical trials conducted in the past 15 years, a network of excellence has been established across Europe and Israel, including 50 specialty psychiatric clinics, academic hospitals and general hospitals. By joining forces within this unique international network, we are able to successfully complete large studies much faster, pushing scientific progress, which is essential for improvements in daily clinical practice.
The aim of the International Clinical Trial Center is to conduct successful international clinical research projects that lead to a better understanding of the biological basis of psychiatric disorders and improvements in patient care. This group is led by Dr. Inge Winter, senior trial manager with special expertise in the field of schizophrenia and related disorders who coordinated several large studies that provided fundamental evidence regarding optimal treatment of psychotic disorders. Inge is involved in several academic groups, including Oxford University, King’s College London and New York’s Sinai Medical Center. She manages a group of researchers who implement and coordinate large-scale trials across Europe and Israel, through funding by the European Commission, the Stanley Medical Research Institute and unrestricted grants. These trials mostly focus on the treatment of psychosis, although studies on major depressive disorder, Alzheimer's and autism have also been conducted. For most projects, the team takes on all clinical trial management responsibilities: from writing the protocol and Standard Operation Procedures, designing randomisation modules and the eCRF, centralised and on-site monitoring, safety reporting up until writing publications in international peer-reviewed journals.
The International Clinical Trial Center has successfully managed clinical trials and non-intervention studies in the field of psychiatry, specialising in (early-stage) psychosis. This is demonstrated by our accomplishments with the OPTiMiSE trial (Study Details | Optimization of Treatment and Management of Schizophrenia in Europe | ClinicalTrials.gov), where 481 First Episode Psychosis patients were recruited across 24 participating centers in Europe and Israel, resulting in over 30 publications so far. Another example is the EULAST trial (Study Details | European Long-acting Antipsychotics in Schizophrenia Trial | ClinicalTrials.gov), where 523 patients with early schizophrenia were recruited across 50 centers in Europe and Israel, so far resulting in multiple publications in Lancet Psychiatry. A recent contribution to the field is the PURPOSE trial (Study Details | Placebo-Controlled Trial in Subjects at Ultra-High Risk for Psychosis With Omega-3 Fatty Acids in Europe (PURPOSE) | ClinicalTrials.gov), where 135 subjects at clinical high risk were treated with omega-3 fatty acids versus placebo. We were able to show that, despite an early positive finding by another research group, omega-3 fatty acids are not able to prevent transition to psychosis nor decrease symptom severity. The PSYSCAN cohort study was unique in following a large European sample of First Episode Psychosis patients for a full year, early in their disease course, establishing a rich deep-phenotyping dataset.
Our group has a close collaboration with the Icahn School of Medicine at Mount Sinai, New York, concerning the (F)NIH sponsored Accelerating Medicines Partnership Schizophrenia (The Accelerating Medicines Partnership (AMP) Schizophrenia (SCZ) Program) and the follow-up Proof of Principle clinical trial currently in preparation. In addition, we work closely with Oxford University concerning the three Wellcome Trust sponsored, world-wide trials as part of the STEP project, investigating the efficacy of augmentation with cannabidiol versus placebo in clinical high risk (for psychosis) subjects, patients with first episode psychosis and patients with treatment resistant psychosis.
Center for Clinical Neuroscience and Cognition
University Medical Center Groningen
Triade building, entrance 24, room KZ1.06
Groningen
The Netherlands
