Work Packages
Lead
Farmaceutski Fakultet Universitetau Beogradu
Faculty of Pharmacy
Prof Marin Jukic
Co-Lead
Universitätsklinikum Bonn
Institute of Human Genetics
Prof. Markus Nöthen
Participants/Support
- Karolinska Institute
- Parnassia Groep BV
Goals
- Establish logistics for sample collection, processing, storage and shipment at the clinical centres as well as effective communication between clinical centres and central facilities
- Building of the PSY-PGx DNA biobank
- Development of the PSY-PGx cellular biobank
- Perform genotyping for common genetic variants throughout the clinical trial
- Perform retrospective therapeutic drug level quantification
- Interpretation of the results obtained in collaboration with WP5 (Clinical Study)
Lead
Fundació Clínic per la Recerca Biomédica
Department of Psychiatry & Psychology
Prof. Eduard Vieta
Co-Lead
University Maastricht
Department of Psychiatry and Neuropsychology
Prof. Thérèrese van Amelsvoort
Participants/Support
- King's College London
- Global Alliance of Mental Illness Advocacy Networks
- Fundació Clínic per la Recerca Biomédica
- SUNY Upstate Medical University
- Universitätsklinikum Bonn
Goals
- Maintain an stringent strategy for clinical data collection
- Finalize the Clinical Study Document
- Monitoring and site visits
- Quality control
- Set-up training for clinical staff and patients
Lead
Rijksuniversiteit Groningen
Groningen Institute of Evolutionary Life Science & Engineering (BEHAPP)
Prof. Martien Kas
Co-Lead
Tel Aviv University
Sackler Faculty of Medicine
Prof. Noam Shomron
Participants/Support
- Parnassia Groep BV
- Rijksuniversiteit Groningen
Goals
Prepare the IT foundation for the clinical trial to support the phenotyping of patients during the clinical study via apps.
Lead
Universitatea Babeş-Bolyai
Department of Psychology
Dr. Ramona Moldovan
Co-Lead
Ludwig-Maximilians-Universität München
Institute of Psychiatric Phenomics and Genomics
PD Dr. Urs Heilbronner
Participants/Support
- Global Alliance of Mental Illness Advocacy Networks
- World Psychiatric Association
- Parnassia Groep BV
Goals
- Define the project security policy and assess the implications and impact on different factors (ethical, psychosocial and economic) that will determine the future adoption of the PSY- PGx approach.
- Provide reliable information to stakeholders within different healthcare systems across Europe and beyond.
Lead
Parnassia Groep BV
Department of Psychiatry
Ass. Prof. Roos van Westrhenen
Co-Lead
University Maastricht
Department of Psychiatry and Neuropsychology
Prof. Koen Schruers
Participants/Support
- Rijksuniversiteit Groningen
- Tel Aviv University
- All clinical sites
Goals
- Use CASTOR to provide a sustainable data infrastructure relying on a powerful IT framework adhering to the highest standards of data protection
- Adhere to the FAIR Guiding Principles for scientific data management and stewardship (findability, accessibility, interoperability, reusability)
- Design and maintain a stringent strategy to support the work of the consortium by setting up a consortium-stakeholder network, drawing from the diversity of the disciplines involved.
Lead
Helsinki University
Institute for Molecuar Medicine Finland FIMM & Department of Public Health
Prof. Jaakko Kaprio
Co-Lead
King’s College London
Institute of Psychiatry, Psychology & Neurosciences
Prof. Allan Young and Dr. Mario Juruena
Participants/Support
- Tel Aviv University
Goals
Big data will be obtained from Finnish and UK genetic databases to assess pharmacogenetic genotype and clinical outcomes in patients with mood-, anxiety or psychotic disorders to investigate real-world, large-scale and long-term perspectives on outcomes of specific disease – medication stratified by CYP2C19 and CYP2D6 genotype.
Lead
Co-Lead
Universitätsklinikum Bonn
Klinik für Psychiatrie und Psychotherapie
Prof. Alexandra Philipsen
Participants/Support
- All clinical centers
- Rijksuniversiteit Groningen
Goals
- Conduct the 24-week randomized, patient- and rater-blind, two-arm, parallel-group controlled trial of pharmacogenetics-informed pharmacotherapy in 9 centers across 7 European countries and the US. This will be done in n=2500 patients starting or alternating psychopharmacotherapy for mood disorders (group 1, n=1250), anxiety disorders (group 2, n=750), and psychotic disorders (group 3, n=500).
- Big data will be obtained from Finnish and UK genetic databases to assess pharmacogenetic genotype and clinical outcomes in patients with mood-, anxiety or psychotic disorders to investigate real-world, large-scale and long-term perspectives on outcomes of specific disease – medication stratified by CYP2C19 and CYP2D6 genotype.
Lead
Tel Aviv University
Sackler Faculty of Medicine
Prof. Noam Shomron
Co-Lead
Parnassia Groep BV
Department of Psychiatry
Ass. Prof. Roos van Westrhenen
Participants/Support
- Helsinki University
- Rijksuniversiteit Groningen
Goals
Develop an algorithm with data from the Biobanks from WP4 and the Clinical Trial in WP5
Lead
Ludwig-Maximilians-Universität München
Institute of Psychiatric Phenomics and Genomics
PD Dr. Urs Heilbronner
Co-Lead
SUNY Upstate Medical University
Department of Psychiatry
Prof. Thomas G. Schulze
Participants/Support
- Global Alliance of Mental Illness Advocacy Networks
- World Psychiatric Association
- Parnassia Groep BV
Goals
- Raise awareness of PSY-PGx
- Involve stakeholders throughout the project
- Communicate, disseminate and exploit the results achieved adhering to Open Science principles
Lead
Parnassia Groep BV
Department of Psychiatry
Ass. Prof. Roos van Westrhenen
Co-Lead
Universiteit Maastricht
Department of Psychiatry and Neuropsychology
Prof. Bart Rutten
Participants/Support
- Universitatea Babeş-Bolyai
- World Psychiatric Association
- Ludwig-Maximilians-Universität München
Goals
Facilitate the successful completion of the project