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Effects of Psilocybin in Patients With Amyotrophic Lateral Sclerosis

NCT06656702 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-01-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Psilocybin

Psilocybin Trihydrate. 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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • Johns Hopkins University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-09
Primary Completion
2027-01-30
Completion
2027-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06656702 on ClinicalTrials.gov