Norrsken Mind is co-funding a planned study at Østfold Hospital to evaluate MDMA-assisted psychotherapy as a treatment for young adults (aged 18-25) with major depressive disorder. The study is led by Ole Andreassen, Professor at University of Oslo, in collaboration with Eva Henje, Professor at Umeå University, Mark Berthold-Losleben, consultant psychiatrist at Østfold Hospital and Associate Professor at Norwegian University of Science & Technology, and Tor-Morten Kvam, consultant psychiatrist at Østfold Hospital and doctoral student at University of Oslo. 

Major depressive disorder (MDD) is a leading cause of disability among young people globally. Early-onset depression significantly increases the lifetime risk of recurrent depressive episodes with high relapse rates persisting into adulthood. Many young patients with MDD do not benefit from available treatments, and approximately 50% of all MDD patients fail to respond to first-line antidepressants, highlighting the urgent need for new effective treatment options.

MDMA-assisted therapy (MDMA-AT) has gained attention for its promising results in treating post-traumatic stress disorder (PTSD). Clinical studies have shown that MDMA-AT can significantly reduce PTSD symptoms, earning "breakthrough therapy designation" from the U.S. Food and Drug Administration (FDA). However, its potential in treating MDD in young adults has not yet been explored.

MDMA-AT is believed to enhance therapeutic outcomes by fostering emotional openness, reducing fear responses, and strengthening the therapeutic alliance between patients and therapists. This study is an open-label proof of principal study and aims to assess the feasibility, safety, and therapeutic potential of MDMA-AT using a flexible dosing protocol. The trial will enroll twelve (N=12) participants aged 18-25 diagnosed with MDD.