Reunion Neuroscience presented the design of its REKINDLE Phase 2 clinical trial, which will evaluate RE104 for treating adjustment disorder (AjD) in patients with cancer and other medical illnesses. RE104 is a prodrug of 4-OH-DIPT designed to induce a shorter psychedelic experience than psilocybin. The study design was unveiled at the 2025 Anxiety & Depression Association of America Conference.
This trial is crucial because AjD, characterized by a disproportionate reaction to stressors, lacks FDA-approved treatments and significantly affects the quality of life for those with serious medical conditions, like cancer. Addressing AjD could improve not only mental health outcomes but also physical health outcomes and treatment compliance in these patients. The development of a rapid-acting, effective treatment for AjD could significantly improve their overall well-being and potentially reduce healthcare utilization.
The REKINDLE trial will be randomized, double-blind, and dose-controlled, measuring changes in depression severity using the MADRS scale and anxiety severity using the HAM-A scale at day 14. Reunion Neuroscience is also conducting the RECONNECT trial, evaluating RE104 for postpartum depression (PPD), a condition with similar characteristics to AjD. Initial data from this trial is expected mid-2025, around the same time the REKINDLE trial is expected to commence.
The simultaneous progression of these two trials represents a substantial step forward in addressing significant unmet needs in mental health. Positive results could establish RE104 as a groundbreaking treatment for both AjD and PPD, transforming the landscape of mental health care for patients facing significant life stressors and medical illnesses. This could also signal a shift towards broader acceptance and implementation of psychedelic-inspired therapies within traditional medicine.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
