Amyotrophic Lateral Sclerosis study: Psilocybin
Official title Effects of Psilocybin in Patients With Amyotrophic Lateral Sclerosis
ClinicalTrials.gov ID: NCT06656702
What this study is testing
What is Psilocybin?
This is an investigational medicine being studied to see if it can help with depressed mood in people with Amyotrophic Lateral Sclerosis (ALS). It is designed to affect brain chemicals that influence mood and perception.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if giving psilocybin is doable for ALS patients with low mood and to check if it changes their depression, quality of life, feelings of hopelessness, and daily functioning.
- Who it's for
- Adults with amyotrophic lateral sclerosis who are experiencing depressed mood.
- What's involved
- Participants will receive psilocybin in a controlled setting and will be monitored with mood and health questionnaires.
- Time commitment
- The study lasts a few weeks, with several clinic visits for dosing and follow‑up assessments.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Clinically significant depressive symptoms as evidenced by an Assessment of Depression Inventory (ADI)-12 score \>22.
You likely can't join if
- Patients with severe speech impairments, including those who are nonverbal, require assisted speech devices, and those who can only communicate by...
- 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...
- Epilepsy with history of seizures
See the full eligibility criteria
- 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.
- 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...
- Epilepsy with history of seizures
- 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...
- 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...
- Currently taking Nuedexta (dextromethorphan/quinidine combination), efavirenz, Acetaldehyde dehydrogenase inhibitors such as disulfiram (Antabuse), Alcohol dehydrogenase inhibitors, or UGT1A9 inhibitors or UGT1A10...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Baltimore, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.