Status: Planned (December 2026)
Funding: Helse Sør-Øst Regional Health Authority (HSØ) PhD Fellowship (~NOK 4 million) and the Norrsken Foundation (SEK 5 million)
The Empathy Project is a randomized pilot study evaluating MDMA-assisted therapy in young adults (18–25 years) with chronic treatment-resistant depression (TRD). The study will enroll 16 participants, randomized in a 1:1 ratio (2 × 8 participants), to evaluate the feasibility of recruitment, randomization, participant retention, study procedures, and treatment delivery. The project combines a randomized pilot trial with a single-case experimental design (SCED), enabling detailed longitudinal assessment of individual treatment trajectories and potential mechanisms of change. Together, these data will inform the design and implementation of a future larger randomized clinical trial.
Project Leads: Tor-Morten Kvam, Mark Berthold-Losleben and Ole A. Andreassen
PhD Candidate: Hilde Paulsen
Main Supervisor: Tor-Morten Kvam
Co-supervisors: Mark Berthold-Losleben and Ole A. Andreassen