Mirabilis Health Institute and Transcend Therapeutics have announced the launch of Northern Ireland’s first clinical trial for psychedelic-assisted therapy using a next-generation compound, methylone. This revolutionarynew compound is a non-hallucinogenic treatment for neuropsychiatric conditions, specifically post-traumatic stress disorder (PTSD). The study will evaluate the safety, tolerability, and efficacy of methylone in adults with PTSD.
Post-traumatic stress disorder (PTSD) is a debilitating condition that can affect anyone who has experienced or witnessed a traumatic event, such as military combat, sexual assault, or a natural disaster. It is estimated that around 3.5% of the global population suffers from PTSD, and it can have severe and long-lasting effects on the individual’s mental and physical health. While there are currently some treatments available for PTSD, they are often ineffective or have significant side effects.
Recent research has shown that psychedelic-assisted therapy, particularly using MDMA, can be an effective treatment for PTSD. The Multidisciplinary Association for Psychedelic Studies ( MAPS) has been leading the way in MDMA-assisted therapy for PTSD, with several successful clinical trials conducted around the world. In a Phase 3 clinical trial, MDMA-assisted therapy showed a significant reduction in PTSD symptoms, with 67% of participants no longer meeting the criteria for PTSD after just three sessions. These ground-breaking results have led the US Food and Drug Administration (FDA) to grant MDMA-assisted therapy breakthrough therapy status, paving the way for its eventual approval as a treatment for PTSD.
The study being conducted by Mirabilis Health Institute and Transcend Therapeutics will evaluate the safety, tolerability, and efficacy of methylone in adults with PTSD. Eligible participants will receive methylone once weekly for four weeks (four treatment sessions) during a four-week treatment period. Following the treatment period, participants will enter a six-week follow-up period that includes three reflection visits (week 4, 5, and 6) and a final study visit at week 10. The study aims to determine if methylone is an effective and safe treatment for PTSD.
Mirabilis Health Institute and Transcend Therapeutics are excited to be at the forefront of this ground-breaking research and are committed to finding new and effective treatments for trauma. The study is being conducted under strict ethical and regulatory guidelines and will adhere to the highest standards of patient care and safety.
Commenting on the launch of the study, Professor Paul Miller MD, Medical Director of Mirabilis Health Institute said: “PTSD is a debilitating condition that can have a significant impact on a person’s life. We are thrilled to be able to offer this innovative treatment option to our patients and are committed to conducting the study to the highest standards. We hope that this study will provide valuable insights into the potential of psychedelic therapy as a treatment for PTSD.”
“The advancements being made right now around mental healthcare, and at Transcend in particular, reminds me of the internet in 1996; even the most hopeful people underestimate its impact on the world. The work that Transcend is doing has the potential to completely change how people are treated for PTSD and depression,” Transcend Co-Founder and Chairman, and AlleyCorp Founder and CEO Kevin Ryan said. “We’ve brought together the world’s leaders in drug development and psychiatric research, and together we’re pushing this industry into new, highly promising territory.”
The launch of this study is a significant milestone in the field of psychedelic-assisted therapy for PTSD, and it is hoped that the results will provide valuable insights into the potential of methylone as a rapid-acting, disease-modifying treatment for this debilitating condition.