This open-label trial (n=24) will assess the feasibility of psilocybin therapy in patients with Amyotrophic Lateral Sclerosis (ALS) experiencing depressed mood. Participants will undergo an 8-week treatment course, including two psilocybin sessions (15 mg in week 4 and 15 or 25 mg in week 6), with follow-up assessments at 1, 3, and 6 months post-treatment.
Proof-of-concept, single-group, open-label interventional trial of psilocybin in treatment-seeking patients with ALS and clinically significant depressive symptoms; primary aim is feasibility and secondary aims include depression, quality of life, hopelessness, and functional status.
Participants complete an 8-week course with two psilocybin dosing sessions (week 4: 15 mg; week 6: 15 or 25 mg) and follow-up visits at 1, 3, and 6 months to assess safety, mood, and function.
Single-group, open-label psilocybin treatment arm with two dosing sessions embedded in an 8-week course.
Session 1: 15 mg (week 4); Session 2: 15 mg or 25 mg (week 6). Psilocybin trihydrate tablets.