Psilocybin for ALS and Depressed Mood

This study is looking at whether psilocybin (a drug) can be a practical treatment for people with Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease, who also experience depressed mood. The study will also explore how psilocybin might affect depression, quality of life, feelings of hopelessness, and daily function for these patients. Up to 24 participants will be enrolled. To join, you must be at least 18 years old, have a diagnosis of ALS, and have good lung function (forced vital capacity >60%). The main goal is to see if psilocybin treatment is feasible, meaning if people can be recruited, stay in the study, and follow the treatment plan. The current recruitment status is unclear.

Study design
This is an open-label study, meaning you and the researchers will know what treatment you are receiving. It's a single-arm study, so all participants will receive the psilocybin treatment. Up to 24 people are planned to join.
What's involved
You would complete an 8-week treatment course, including two psilocybin sessions. These sessions are planned for week 4 (15 mg) and week 6 (15 or 25 mg).
Compensation
Not stated in the trial record.
Follow-up
You will have follow-up assessments 1, 3, and 6 months after your last psilocybin session.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06656702

Effects of Psilocybin in Patients With Amyotrophic Lateral Sclerosis

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Johns Hopkins University
~24 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:Psilocybin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of psilocybin treatment as assessed by number of participants recruited, retained and adhere to treatment
Measured over 6 months
Amyotrophic Lateral Sclerosis

NCT06656702

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Johns Hopkins Center for Psychedelic and Consciousness Research

    Baltimore, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Ambereen K Mehta, MD, MPH, FAAHPM · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Opens a ready-to-send draft in your own email app — review before sending.

  • Feasibility of psilocybin treatment as assessed by number of participants recruited, retained and adhere to treatment6 months

    feasibility will be assessed by participant recruitment, retention, and treatment adherence.