A Stratified Treatment Algorithm in Psychiatry: A program on stratified pharmacogenomics in severe mental illness


Concept of the project

Psych-STRATA is a research project funded by the European Commission that focuses on personalised mental health treatment.

The project tackles treatment resistance (TR), a problem affecting a third of patients with major mental disorders who don't respond to drug therapy. These patients often face a trial-and-error treatment approach, which is inefficient and stressful.

The main aim is to address this by identifying at-risk individuals earlier, developing personalised treatment strategies grounded in the biological basis of TR, and efficiently implementing these insights in clinical practice and treatment guidelines.

Psych-STRATA will examine diverse data, including genetic, biological, digital mental health, and clinical information to better understand TR and identify those at risk. Using Europe-wide clinical trial information, the project will determine optimal treatment strategies for those at risk of TR.

The research will aid in the creation of new machine-learning models to predict TR risk and treatment response. Finally, the project aims to integrate these findings into clinical practice, assisting clinicians and patients in making informed treatment decisions.

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A Stratified Treatment Algorithm in Psychiatry:

A program on stratified pharmacogenomics in severe mental illness (Psych-STRATA).

Grant agreement No: 101057454.


1 Oct 2022


30 Sept 2027

Coordinated by

The University of Münster (Westfälische Wilhelms-Universität Münster, WWU)

Total cost

€ 10.8 million


Our mission is to pave the way for a shift towards a treatment decision-making process tailored for the patients at risk for treatment resistance. To achieve this, we will:

Understand the genetic basis of TR

We are working to find genetic markers that can identify people at risk of Treatment Resistance (TR), in other

words patients that are not responding well to treatments for schizophrenia, bipolar disorder, and major depressive disorder. We look at genetic and clinical data, study genetic links, analyse genes and cell types, and validate these genetic predictors. This could help spot people at risk early on based on their genetic makeup, which could change how we make future clinical decisions.

Uncover TR

We aim at finding genes, proteins, and other biological information that
could tell us in advance

We aim at finding genes, proteins, and other biological information
that could tell us in advance

who might not respond well to treatments for schizophrenia, bipolar disorder, and major depressive disorder. We will also check how well these methods work by testing them on patients’ cells. All this will help us predict who might struggle with treatment and find new ways to help them. This work will make our treatment methods better and more personalised.

Evaluate efficacy in a clinical setting

Our goal is to test if stronger medicine given early can help people with schizophrenia, bipolar disorder, and

major depression who did not improve after an initial treatment. These tests will also help us understand if our biomarkers work in real-life settings. The information we gather will not only contribute to our other objectives but also has the potential to change how these mental health conditions are treated, helping many patients across Europe. We’ll see if this approach helps with other symptoms, if it works better taking into account certain biomarkers, and if digital tools can help us measure success. This valuable data will be used in further studies and to create a decision-making tool for treatment.

Predict treatment
response success

We are going to set up ways to predict if intense treatment will work for those whose first treatment did not help,

for different mental health conditions. We will use the data from our earlier tests to do this. Our steps will include studying samples from our tests, finding biological markers linked to treatment results, validating these markers, and creating a machine-learning model to predict treatment response. This will help us understand who is at risk of not responding to treatments. All this information will set the groundwork for the creation of a tool to help decide on the best treatment options.

Develop a decision-making tool

Our goal is to use the findings from our first four objectives to improve real-world treatment. We plan to create

a system that can identify early if a patient (with conditions like schizophrenia, bipolar disorder) might not respond well to treatment, and suggest alternative treatments. We will do this by developing a tool driven by data and setting up a process that puts the patient at the centre of decision-making. The system will be tested in everyday clinical care. The information we gather from our earlier work will be used to see how it can help predict who might not respond well to treatment. We will test this system locally, nationally, and internationally, taking us a step closer to personalised mental health care. We also aim to create a plan for introducing treatment guidelines for early detection and decision-making in severe and resistant cases of schizophrenia, bipolar disorder. There is nothing like this in the field of psychiatry right now, so we believe this work could be a game-changer for treating these conditions. This could also guide us in addressing other mental conditions.

Involve patients & other stakeholders

We aim to share our findings with everyone - from people directly affected by mental illness to policymakers and

healthcare providers. We want to involve everyone in our project, empower patients and their families, and communicate the importance of personalised mental health care. We will also share our project’s goals and results with key groups like researchers, healthcare providers, policymakers, and patients.

Work packages

Psych-STRATA workplan has been distributed into seven work packages

Transdiagnostic biosignatures for TR

Leader - CARDIFF


Leader - UNIBO

Early Intensive

Leader - UMCU

treatment signatures

Leader - WWU

decision board

Leader - Fraunhofer

Patient empowerment, dissemination, & education

Leader - LMU

Coordination &

Leader - WWU

Meet the team leaders

Get to know the passionate professionals who are driving this innovative project forward.

Prof. Bernhard Baune

(PhD, MD, MPH, FRANZCP), Coordinator, WWU

Meet the partners

Psych-STRATA unites 26 partners and 15 clinical trial sites from Australia, Austria, Belgium, Denmark, France, Germany, Israel, Italy, Norway, Spain, Sweden, Switzerland, the Netherlands, and the United Kingdom, encompassing academia, research, health care, patient organisations, and information technology. Click here to meet our clinical trial sites.

Frequently asked questions

Visit our frequently asked questions page, and find in-depth information and solutions to commonly asked questions and concerns.

Transdiagnostic biosignatures for TR

Leader - CARDIFF

The objective of this Work Package is to identify transdiagnostic biosignatures related to treatment resistance (TR) in schizophrenia, bipolar disorder, and major depressive disorder by analysing genetic and clinical data from large cohorts. This will be achieved through several tasks, including harmonising genetic and clinical data, conducting Genome-wide association studies of TR, analysing data at the single-cell, tissue, gene, and pathway level, optimising and validating genetics-based predictors of TR. Results of this WP will be integrated into machine learning models of TR to be developed in other WPs.

Multi-modal biosignatures

Leader - UNIBO

This Work Package's aim is to identify multi-modal biosignatures underlying treatment outcome (TO) in schizophrenia, bipolar disorder, and major depressive disorder. This will be achieved through serum proteomic profiling, integration of genetic biosignatures and multi-omic datasets, developing a multi-modal predictor of treatment outcome, and experimentally validating and dissecting the biological basis of biomarkers using induced Pluripotent Stem Cells (iPSCs) derived from patients. The results will be shared with other WPs to develop and implement multi-modal predictors of TO.

Early Intensive Treatment

Leader - UMCU

The objective of this Work Package is to conduct an international, randomised, controlled trial to test the effect of providing an intense treatment, normally reserved for treatment-resistant patients, earlier in the illness course, versus treatment as usual in three patients samples with a diagnosis of schizophrenia, major depressive disorder or bipolar depression. The rich dataset that will be created in the process enables us to identify transdiagnostic biosignatures related to treatment resistance (TR) in schizophrenia, bipolar disorder, and major depressive disorder by analysing genetic, clinical and digital data collected as part of this study. Click here to meet our clinical trail sites.

Multi-modal treatment signatures

Leader - WWU

The central goal of this Work Package is to identify clinical, cognitive, and biological signatures associated with treatment outcomes in patients with first treatment failure of Treatment-As-Usual (TAU) and early intensive treatment. The objective is to combine these associations to establish multi-modal predictors of treatment outcomes by diagnostic group and transdiagnostically. The insights will be disseminated to other WPs as evidence base for translation into clinical practice through guideline development and the development of tools to support treatment decisions. Tasks include multi-omic profiling of longitudinal RCT cohort samples, identification of omic-based biomarkers associated with treatment outcome, integration and validation of biosignatures associated with TR or treatment outcome, the establishment of a multi-modal machine learning model to predict treatment response, and developing artificial intelligence models for modelling and simulating patient trajectories.

Treatment decision board

Leader - Fraunhofer

This Work Package seeks to develop a treatment decision-making mental health board for patients after the first treatment failure, incorporating clinical, biological, and social information. The insights will be used for the implementation of new treatment guidelines for early detection and treatment of patients at risk for severe disease courses. Tasks include implementing an AI-based software tool for treatment decision support, conceptualising and facilitating a decision-making mental health board, and developing a framework for implementation of treatment guidelines for early detection and treatment decision-making in severe and treatment-resistant schizophrenia, bipolar disorder, and major depressive disorder.

Patient empowerment, dissemination, & education

Leader - LMU

The central goal of this Work Package is to involve patients and their needs in the development, implementation, and dissemination of the new detection and treatment strategies evaluated in WPs 4-6. Tasks include evaluating the use of digital apps and continuous mental health assessments, comprehensive evaluation of the novel mental health board, and dissemination and education of findings through patient organisations such as GAMIAN-Europe and the World Psychiatric Association (WPA)

Coordination & management

Leader - WWU

This Work Package involves scientific coordination and project management. The aim of scientific coordination is to ensure that all partners are aware of all activities, make progress, and comply with the EC's requirements. Tasks include coordinating activities within each WP, higher-level coordination by the WP Leaders and Coordinator in the Steering Committee. Project management aims to be an efficient service to project coordination. This includes preparing strategic decisions by the full consortium and Steering Board, providing templates for reporting and checking financial reports. The project management is also keeping records of financial management, providing guidelines and procedures, assisting with the organisation of meetings and conferences, and maintaining the Consortium Agreement.

Prof. Bernhard Baune

(PhD, MD, MPH, FRANZCP), Coordinator, Germany

Prof. Bernhard Baune is a distinguished psychiatrist and neurobiology researcher and currently serves as the Head of the Department of Psychiatry at the University of Münster. He has an extensive research background in the neurobiology of severe mental illnesses, treatment response, and immune-neurobiology of psychiatric disorders. Prof. Baune leads two EU-funded research consortia, EraPerMed: PROMPT and Psych-STRATA, focused on personalised treatments for major psychiatric disorders. He has published over 660 peer-reviewed articles, reviews, and book chapters. Prof Baune is recognised internationally for his expertise and contributions to psychiatry, particularly in the field of personalised medicine.

Prof. James Walters

WP1 leader, Wales

Professor James Walters, Director of the Centre for Neuropsychiatric Genetics and Genomics, is renowned for advancing neuropsychiatric genetics research. His work delves into understanding psychosis and schizophrenia through genetics, probing treatment-resistant schizophrenia's underpinnings and studying cognitive deficits across the psychosis spectrum. Concurrently, he serves as Deputy Director of the National Centre for Mental Health and consults for Aneurin Bevan University Health Board's Early Intervention in Psychosis Service, bridging academic exploration and practical application. In education, he spearheads the C21 Medical Undergraduate Psychiatry curriculum, earning accolades for his inventive teaching methods. His research is bolstered by prestigious grants from the MRC, Wellcome Trust, and Brain and Behaviour Research Foundation, and he supervises several promising students and research projects across diverse disciplines. In recognition of his exemplary work, he received Cardiff University's Dean of Research Excellence Award in 2016, preceded by the Baer Prize for Innovative Research in Schizophrenia in 2012. Through his multifaceted contributions, Professor Walters persistently enhances neuropsychiatric genetics understanding.

Prof. Dr. Stephan Ripke

WP1 co-leader, Charite

Prof. Stephan Ripke, Dr. med., PhD, is the Head of Experimental Psychiatry and (Epi)Genomics and the Laboratory for statistical genetics. With a passion for computational methods in genetic research since his early medical training, Prof. Ripke combines his exceptional computational and statistical expertise with medical and clinical knowledge to navigate every crucial step of genetic analysis. This includes handling raw genotypic data, conducting essential tasks like quality control, imputation, meta-analysis, and principal component analysis, and deriving meaningful medical and clinical insights from the findings. His significant contribution lies in leading statistical analyses for the Psychiatric Genomics Consortium, the largest collaborative effort in psychiatric genetics. This involvement has granted him a deep understanding of the future requirements necessary for sustaining the Consortium's impressive achievements. Prof. Ripke firmly believes that collecting new samples from individuals with psychiatric disorders, alongside well-matched, recontactable controls, is a highly valuable contribution to advance psychiatric research. While maintaining his central role in the Psychiatric Genomics Consortium, Prof. Ripke has also joined Charite, a renowned teaching hospital in Berlin, Germany. Since 2015, he has been establishing the BePS cohort, generously funded by the BBRF (Brain and Behavior Research Foundation).

Dr. Chiara Fabbri

WP3 leader, UMCU

Dr. Chiara Fabbri is a psychiatrist and researcher, focusing on genetic factors influencing psychotropic drug response and mood disorder heterogeneity. She's an Assistant Professor of Psychiatry at the University of Bologna, Italy, and a Visiting Researcher at King's College London. With a PhD in psychiatric pharmacogenetics from the University of Maastricht, she's made significant strides in identifying genetic predictors of treatment-resistant depression (TRD) and characterising depression subtypes. Her innovative research uses genetic predictors for drug repositioning and electronic health records to boost sample sizes for pharmacogenetic studies. Currently, she's dedicated to discovering biomarkers that enable patient stratification and personalised health care. Dr. Fabbri's expertise in treatment efficacy and biological markers is invaluable to the Psych-STRATA project.

Dr. Inge Winter

WP3 leader, UMCU

Dr Inge Winter is a professional in clinical trial design and project management, honed her expertise at Eli Lilly's Medical Department (NL) for six years, focusing on Phase I and III psychiatry studies. For four years, Dr Winter juggled a Medical Liaison role for Zyprexa/ZypAdhera, liaising with key opinion leaders, while successfully earning her PhD in bipolar disorder. Now leading a 12-member research group at UMCU, Inge has co-authored papers in prestigious journals and secured research grants in international consortium applications. Dr Winter also oversees three global clinical trials in psychosis and serves as a senior project manager at the University of Oxford. Since October 2020, she is part of the leadership team for a large NIMH-funded project (U24) through her associate professorship at Mount Sinai, New York.

Prof. Dr. Oliver Howes

WP3 Co-leader, KCL

Oliver Howes, a renowned Professor of Molecular Psychiatry at King's and Imperial Colleges in London, heads the Department of Psychosis Studies and consults at The Maudsley Hospital. His research focuses on the root causes of mental illnesses and advancing treatments related to dopamine, GABA, glutamate, and the immune system. With over 400 scientific papers published, Professor Howes has earned recognition for his contributions. He has received prestigious awards such as the American College of Neuropsychopharmacology Award for Translational Research, Royal College of Psychiatrists Researcher of the Year Award, among others. Despite his achievements, Professor Howes remains grounded and pursues various interests. He once worked as a farm potato scrubber and received an award from STRAVA during lockdown for being the neighborhood's downhill running enthusiast. In his free time, he passionately seeks out the world's finest ice cream.

Dr Michael Ziller

WP4 leader, WWU

Michael is an accomplished physicist and bioinformatician specializing in functional genomics and induced pluripotent stem cell (iPSC) technology. As the leader of a hybrid wet-dry lab, he steers a multi-disciplinary team aimed at unraveling the genetic underpinnings of psychiatric disorders, including schizophrenia, bipolar disorder, and depression. The lab harnesses the power of patient-derived iPSC models, high-throughput genetic screening, and a variety of functional genomics assays. Committed to fostering innovation, Michael's team also pioneers computational techniques for synthesizing multi-omic datasets, offering new insights into the intricate complexities of polygenic diseases.

Dr. Marie-Claude Potier

WP4 co-leader, ICM

Dr. Marie-Claude Potier, Research Director at the CNRS, co-leads the Alzheimer’s and prions diseases team at ICM (Paris Brain Institute), Salpêtrière Hospital, Paris. She has a 25-year tenure in Down Syndrome (DS) research, focusing on genomics, genetics, and pharmacological treatment development to enhance cognition. Currently, she explores early Alzheimer’s stages in DS patients. Using genomics tools, her work includes systematic RNAseq and single-cell RNAseq analysis to study individual neuronal gene expression in disease states. In the PsychSTRATA project, her team performs RNAseq from patient blood samples. Professor Philippe Fossati, MD PhD from ICM, is a part of the consortium. Read more about the ICM team here. Two core facilities from ICM, the iGenSeq platform and the Data Analysis Core, support the project by performing globin depletion and RNAseq on patient samples, and by conducting analysis and quality control of the RNAseq data respectively.

Prof. Dr. Holger Froehlich

WP5 leader, SCAI

Prof. Dr. Holger Fröhlich is a renowned computer scientist with expertise in Artificial Intelligence (AI) and Data Science. With a Diploma and PhD in Computer Science, he has held various positions in prestigious institutions such as the German Cancer Research Center and Cellzome AG (now part of Glaxo-Smith-Kline). In 2010, he became an associate professor at the University of Bonn, and later joined UCB, a global biopharmaceutical company, as the Director of an AI and Data Science research team. Currently, he serves as the Head of the AI & Data Science group and Deputy Head of the Department of Bioinformatics at the Fraunhofer Institute for Algorithms and Scientific Computing. Additionally, he is an honorary professor at the University of Bonn, teaching in the Master programs of Life Science Informatics and Computer Science. With a focus on Precision Medicine, early Drug Discovery, and System Medicine, Prof. Dr. Fröhlich specializes in developing machine learning algorithms. Over the past two decades, he has contributed to various research projects and consortia, publishing over 150 papers. Notable projects include IDENTIREST, AETIONOMY, RADAR-AD, The Virtual Brain Cloud, NFDI4Health, DIGIPD, ADIS, IDERHA, and Real4Reg.

Dr. Sergi Papiol

WP6 leader, LMU

Dr. Sergi Papiol is a biologist with a PhD in imaging genetics from the University of Barcelona. His main interest focuses on the genetic variability that contributes to the complex phenotype of affective- and psychotic-spectrum disorders in human populations. He is the leader of the Genomics group at the Institute of Psychiatric Phenomics and Genomics (IPPG) at the Ludwig Maximilian University of Munich. He coordinates the second wave of training and data recruitment of the Consortium on Lithium Genetics (ConLiGen) since 2018. He is currently a member of the research team of the ERANET-Neuron project GEPI-BIOPSY and the Spanish MInistry-funded project SATURNO. In close collaboration with GAMIAN-Europe partner, he co-leads this work package dedicated to Dissemination involving patients' organisations, professional societies, and scientific community.

Erik Van der Eycken

WP6 co-leader, GAMIAN-Europe

Erik Van der Eycken is a passionate advocate for mental health, bringing his personal experience and expertise to various organizations and initiatives. He serves as a Board Member of the patient organization 'Ups & Downs,' representing individuals living with bipolar disorder. Additionally, Erik actively participates in OpGanG, an association in Belgium that supports people with mental health challenges. He represents patient interests at RISIV-INAMI, an advisory body on chronic diseases, and serves as an independent Director on the Board of OPZ, a renowned psychiatric hospital. Since 2014, he has been involved in EU-funded mental health research projects, representing patient perspectives for GAMIAN-Europe. Erik's background includes a Master's Degree in electromechanical engineering and a career in R&D projects within the automotive industry. In Psych-STRATA, he co-leads WP6, focusing on patient integration and dissemination activities.