RESET – Medication
REStoring mood in Early life Trauma
The RESET-medication study is a 6-week double-blind placebo-controlled randomized trial testing the efficacy of a 1-week treatment of the glucocorticoid receptor antagonist mifepristone (+ treatment as usual) in 158 patients with a depression and childhood trauma. By blocking the glucocorticoid receptor (GR) using the drug mifepristone, we aim to reverse the biological sequelae of excessive stress due to childhood trauma and improve depression outcomes. We also aim to understand the underlying mechanisms of this potential new treatment strategy by assessing stress-related biomarkers including cortisol, inflammation, and epigenetic regulation.
In a fMRI sub-study, participants (N=80) will undergo pre- and post-treatment scanning including structure, resting-state and various cognitive tasks. Neurobiological effects are assessed in relation to the clinical efficacy of mifepristone.
The RESET-medication RCT is sponsored by the Dutch Brain Foundation (Hersenstichting). The RESET-medication fMRI sub-study is sponsored by the NWO-VIDI grant from ZonMw.
Coordinating RCT researcher: drs. Felix Linsen
Coordinating fMRI researcher: drs. Caroline Broeder
Principal Investigator: prof. dr. Christiaan Vinkers