Taking Personalized Medicine Seriously – Biomarker Approaches in PhaseIIb/III Studies in Major Depression and Schizophrenia

Co-Chairs: Harald Murck, MD; Thomas Laughren, MD

The efficacy of standard antidepressants in comparison to placebo is low.  Approved standard of care antidepressants lead to just one more responder out of ten patients in comparison to placebo. There is also a trend toward smaller effect sizes and higher failure rates for schizophrenia trials. This is possibly due to variability among patients diagnosed with either depression or schizophrenia, both from a perspective of syndromal differences, but more so on a pathophysiological level. The aim to identify a suitable compound for a given subject for either disorder is far from being achieved, but the foundations have been laid. With the progress of easy to handle functional biomarker approaches this goal has now become feasible. One distinction in the utilization of these methodologies is important: 1. characterization of baseline pathology; 2. characterization of (dose related) target engagement for a given subject. Following a presentation of the regulatory environment and requirements for acceptance of biomarkers, case studies will be presented to showcase feasibility and opportunities of this approach in both depression and schizophrenia.   

1. Thomas Laughren, Laughren Psychopharm Consulting: “Regulatory aspects of the use of predictive biomarkers in late stage clinical development of psychiatric drugs”.

2. Femke Lamers; Psychiatric Clinic of the University of Amsterdam, Netherland, PI of the NESDA study: “Biological differentiation of depression subtypes: Salivary Cortisol, inflammatory markers, heart rate variability”.

3. Rosalind Picard, MIT, Boston: “Physiological sensor technology for objective clinical data in psychiatry”.

4. Harald Murck; Covance, Princeton and Psychiatric Clinic of the Philipps-University Marburg, Germany: “Target based biomarker selection – mineralocorticoid receptor related biomarkers and treatment outcome in depression”  (Highlights the combination of slow wave sleep, heart rate variability, salivary endocrine markers for a functional characterization of mineralocorticoid function and its change during antidepressant treatment)

5. Sebastian Walther; University Clinic, Bern, Switzerland: “Actigraphy for the differentiation of schizophrenia subtypes – effects of medication”.

6. Donald Goff; Department of Psychiatry, NYU Langone Medical Center, New York.

7. Jens Wendland; Pfizer.