Effects of Psilocybin in Patients With Amyotrophic Lateral Sclerosis

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.

Conducted by Johns Hopkins University, the study aims to evaluate the impact of psilocybin on depression, quality of life, hopelessness, and functional status in ALS patients.

Feasibility will be determined through participant recruitment, retention, and adherence to treatment. Secondary measures include changes in depressive symptoms (Montgomery–Åsberg Depression Rating Scale and ALS Depression Inventory), quality of life (EuroQoL EQ-5D-3L), hopelessness (Beck Hopelessness Scale), and functional ability (ALS Functional Rating Scale-Revised). The study is expected to commence on 28 February 2025, with primary completion by 30 January 2026 and full study completion by 1 July 2026.

Trial Details

This study aims to study the feasibility of psilocybin therapy for patients with Amyotropic Lateral Sclerosis (ALS) with depressed mood. The secondary objective is to assess its impact on depression, quality of life, hopelessness, and functional status in this patient population. The proposed research's primary objective is to study the feasibility of psilocybin therapy for patients with ALS with depressed mood. The secondary objective is to assess its impact on depression, quality of life, hopelessness, and functional status in this patient population. The proposed proof-of-concept interventional trial will use a single-arm design. The study will be an open-label trial in a sample of up to 24 treatment-seeking patients with a diagnosis of ALS and depressed mood. Participants will complete an 8-week course of study treatment including two psilocybin sessions (15 mg in week 4 and 15 or 25 mg in week 6), with follow-up assessments 1, 3, and 6 months after the final psilocybin session.

Trial Number NCT06656702

Data attribution

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