Amyotrophic Lateral SclerosisEarly Phase 1NCT06656702
Effects of Psilocybin in Patients With Amyotrophic Lateral Sclerosis
A Early Phase 1 study testing Psilocybin in people with Amyotrophic Lateral Sclerosis, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Psilocybin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2025to 1 Jul 2027
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Clinically significant depressive symptoms as evidenced by an Assessment of Depression Inventory (ADI)-12 score >22.
Who cannot join
- 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.
- Cardiovascular conditions: corrected QT interval (QTc) >450 msec, uncontrolled hypertension (i.e., systolic blood pressure (SBP)> 139 mm Hg, diastolic blood pressure (DBP)> 89 mm Hg), resting heart rate (HR)> 90 beats per minute, angina, a clinically significant ECG abnormality (e.g., atrial fibrillation), transient ischemic attack (TIA) in the last 6 months, stroke, peripheral or pulmonary vascular disease (no active claudication).
- Epilepsy with history of seizures
Show all 13Show fewer
- Renal disease (creatinine clearance <40 ml/min using the Cockraft and Gault equation)
- Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
- Females who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control (i.e., intrauterine systems/devices, hormonal methods including implant, shot, patch, ring, or oral contraceptive, condom, diaphragm, sterilization, and abstinence).
- Currently taking medications that interact with psilocybin on a regular (e.g., daily) basis: Atypical antidepressants, such as mirtazapine (Remeron), trazodone (Oleptro), vortioxetine (Brintellix), and vilazodone (Viibryd); Tricyclic antidepressants, such as amitriptyline, imipramine (Tofranil), nortriptyline (Pamelor), desipramine (Norpramin), doxepin, trimipramine (Surmontil), and protriptyline (Vivactil); and Monoamine oxidase inhibitors (MAOIs), such as Selegiline (Emsam), tranylcypromine (Parnate), phenelzine (Nardil) and isocarboxazid (Marplan).
- Currently taking Nuedexta (dextromethorphan/quinidine combination), efavirenz, Acetaldehyde dehydrogenase inhibitors such as disulfiram (Antabuse), Alcohol dehydrogenase inhibitors, or UGT1A9 inhibitors or UGT1A10 inhibitors such as phenytoin, regorafenib, eltrombopag.
- Current or history of meeting Diagnostic and Statistical Manual (DSM)-5 criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I Disorder
- Have a first degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or bipolar I disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Center for Psychedelic and Consciousness Research
Baltimore, Maryland, 21224
Ian Geithner, MPS, 410-550-0037, igeithn1@jhmi.edu
Albert Garcia-Romeu, Ph.D., 410-550-1972, agarci33@jhmi.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Psilocybin
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin | Other | All subjects will be in the same, open label arm Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of psilocybin treatment as assessed by number of participants recruited, retained and adhere to treatment
feasibility will be assessed by participant recruitment, retention, and treatment adherence.
Measured: 6 months
Secondary outcomes (5)
Depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale
Depressive symptoms from baseline at 1 week and 1 month after final psilocybin session measured by the Montgomery-Asberg Depression Rating Scale. Score range: 0-60; higher scores = worse outcome
Measured: Baseline, 1 week post psilocybin session, 1 month post psilocybin session
Depressive symptoms as assessed by the and ALS Depression Inventory
Depressive symptoms from baseline at 1 week and 1 month after final psilocybin session measured by the ALS Depression Inventory. Score ranges from 12 (best) to 48 (worst), with scores between 23 and 29 indicating mild depression and scores above 30 indicating severe depression.
Measured: Baseline, 1 week post psilocybin session, 1 month post psilocybin session
Impact of psilocybin treatment on quality of life as assessed by the EuroQoL 5-dimension, 3-level (EQ-5D-3L) 5-item ALS Assessment Questionnaire
Impact on quality of life measured by the 5-dimension, 3-level EuroQol, 5-item ALS Assessment Questionnaire. Score range 5-25; higher score more problems. The EQ-5D-3L also includes an EQ VAS, which is a vertical scale where respondents rate their health from "the best health you can imagine" to "the worst health you can imagine". The EQ-5D-3L index is calculated by subtracting the descriptive system values from 1, with 1 representing the best possible health status and a value below 0 representing the worst.
Measured: 6 months
Impact of psilocybin treatment on hopelessness as assessed by the Beck Hopelessness Scale
Impact on hopelessness measured by the Beck Hopelessness Scale. Scores range from 0-20 with higher scores indicating a greater degree of hopelessness.
Measured: 6 months
Impact of psilocybin treatment on function as assessed by the ALS Functional Rating Scale-Revised
Impact of function measured by the ALS Functional Rating Scale-Revised. Scale from 0 = can't do, to 4 = normal ability, with a total score range of 0- 52 points. Higher score better outcome.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start9 Apr 2025
- Primary completion30 Jan 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Ambereen K Mehta, MD, MPH, FAAHPM, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656702
- Sponsor's protocol ID
- IRB00408938
- Status last verified
- Aug 2026
- First submitted
- 17 Oct 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No