Psilocybin Therapy to Reduce Depression in Adults with COPD, ALS, MS, or Advanced Parkinsonian Disorders

What this Trial Is About

This research aims to evaluate psilocybin therapy for treating depression and psychological distress in adult patients with chronic obstructive pulmonary disease COPD, amyotrophic lateral sclerosis ALS, multiple sclerosis MS, or atypical and advanced Parkinsonian disorder APD, all with at least a six-month life expectancy. The study focuses on whether psilocybin therapy can safely reduce depressive symptoms compared to a low-dose control and if these effects are rapid and sustained over six months. It also explores impacts on anxiety, demoralization, quality of life, and caregiver burden. Participants will receive psilocybin therapy through three phases preparation, dosing, and integration. The preparation phase involves three psychotherapy sessions to build therapeutic alliance and prepare for dosing. The dosing phase includes two supervised sessions with escalating doses of psilocybin 15 mg followed by 25 mg or two low doses 1 mg for the control group. Integration consists of five psychotherapy sessions to address experiences and psychological themes. Control group participants may optionally receive a high-dose psilocybin session after the initial study period. All dosing and therapy sessions occur in a controlled, supervised setting with trained therapists. During the study, participants will attend preparation, dosing, and integration sessions over about ten weeks, with follow-up assessments at 6 weeks, 3 months, and 6 months after dosing. Researchers will monitor depressive symptoms, anxiety, demoralization, quality of life, adverse events, and other psychological and biological markers. Participants will have access to a digital care platform and peer support during follow-up. Safety and long-term effects of psilocybin therapy will be evaluated throughout the study period.

Psilocybin Therapy for Psychological Distress in Palliative Patients