RESET-medication Glucocorticoid Receptor (GR) Blockade as Disease Modifying Treatment for Depression With Childhood Trauma

• Status: Recruiting
• Trial end date: 2024-06-09

Summary

Depression is a recurrent debilitating psychiatric disorder with a lifetime prevalence of 20%. Even though antidepressants and psychotherapy are often effective, a substantial proportion of patients does not respond to currently used evidence-based treatments. The heterogeneous nature of depressive symptoms is a major obstacle for the development of novel effective treatments, and targeted treatments for depression are currently lacking.

We propose a targeted disease-modifying treatment for the clinically distinct form of depression related to childhood trauma (CT, emotional/ physical/sexual abuse or neglect before the age of18). CT-related depression is critically different from non-CT depression: it emerges earlier in life with more severe and recurrent symptoms and less favorable responses to treatment. With an average 25% prevalence in depression, there is a large and unmet need for therapeutic strategies to treat depression in individuals with substantial CT.

The GR is the major cortisol receptor in the brain and rodent studies have shown that GR blockade at adult age can reverse the effects of early-life adversity. Therefore, GR blockade is a potential novel treatment for CT-related depression but this has never been investigated. Based on the underlying stress neurobiology, we aim to investigate whether we can target the biological sequelae of excessive stress due to CT by blocking the glucocorticoid receptor (GR) using the generic drug mifepristone.

• Phase: Phase 2

Details

• Lead Sponsor: VU University Medical Center
• Collaborators: Corcept Therapeutics; Netherlands Brain Foundation
• Treatments: Mifepristone