The Placebo Biomarker Study
Challenge: The placebo effect is a confounding variable in treatment trials for a number of medical conditions, and is particularly common in CNS studies. For example, 30-50% of depressed subjects in clinical trials have a substantial reduction in symptoms during treatment with a placebo. A method for prospective identification of placebo responders is needed to:
- enhance the efficiency of screening potential antidepressant compounds
- decrease the required size, and resulting cost, of clinical trials
- decrease the number of failed trials
Approach: The focus of this research area will be to identify CNS biomarkers that distinguish placebo responders from non-responders. The study will leverage the Brain Resource Company (BRC) database of integrated clinical biomarkers and the design/infrastructure of the ISPOT-D trial which aims to identify biomarkers associated with depression and treatment response (study drugs: escitalopram, venlafaxine, and sSertraline).
We are currently seeking interested consortium members to collaborate with CBI, the McGovern Institute for Brain Research at MIT, and the BRC on this study. Contact Gigi Hirsch, ghirsch@mit.edu for further information.
Principle Investigator: Alexa Kimball, MD, PhD, Massachusetts General Hospital
Co-leader: Steve Furlong, PhD, AstraZeneca
