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.
Tor-Morten Kvam featured in Swedish National TV (link to SVT Play)
