Effects of Psilocybin in Patients With Amyotrophic Lateral Sclerosis
ConditionAmyotrophic Lateral Sclerosis
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
Qualifiers
Patients aged 18 years and older.
Patients must fulfill ALS El Escorial criteria for possible, probable, laboratory supported probable or definite ALS.
Patients with a pulmonary forced vital capacity (FVC) >50%. The investigators have chosen this measure of function to account for respiratory decompensation during the 6-month longitudinal portion of the study.
Patients with ability to swallow tablets by mouth. Participants may have a feeding tube, but must be able to swallow by mouth and cannot use the feeding tube to administer the psilocybin tablet.
Disqualifiers
Patients with severe speech impairments, including those who are nonverbal, require assisted speech devices, and those who can only communicate by writing or texting.
Patients who are unable to consent for themselves.
Patients with tracheostomy or continuous continuous positive airway pressure (CPAP) or BiPAP.
Known clinical evidence of frontotemporal dementia.
Trial design
Treatments tested in this trial
- Psilocybin
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Johns Hopkins University
Lead sponsor
United States Department of Defense
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov