Effects of Psilocybin in Patients With Amyotrophic Lateral Sclerosis

Launched by JOHNS HOPKINS UNIVERSITY · Oct 22, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the use of psilocybin, a compound found in certain mushrooms, as a potential therapy for patients with Amyotrophic Lateral Sclerosis (ALS) who also experience depression. The main goal is to see if this treatment is practical and how it might improve feelings of depression, overall quality of life, hopelessness, and daily functioning for these patients.

To be eligible for the study, participants need to be at least 18 years old and diagnosed with ALS based on specific medical criteria. They should be able to swallow pills (though having a feeding tube is okay, they can't use it for this medication) and show significant depressive symptoms. However, those with certain serious health conditions, severe speech difficulties, or who are unable to provide their own consent will not be able to participate. If someone joins the study, they can expect to take psilocybin tablets and be monitored over about six months to assess the effects on their mood and quality of life. This study is currently recruiting participants of all genders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients aged 18 years and older.
• • 2. Patients must fulfill ALS El Escorial criteria for possible, probable, laboratory supported probable or definite ALS.
• • 3. Patients with a pulmonary forced vital capacity (FVC) \>60%. The investigators have chosen this measure of function to account for respiratory decompensation during the 6-month longitudinal portion of the study.
• • 4. 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.
• • 5. Clinically significant depressive symptoms as evidenced by an Assessment of Depression Inventory (ADI)-12 score \>22.
• Exclusion Criteria:
• • 1. Patients with severe speech impairments, including those who are nonverbal, require assisted speech devices, and those who can only communicate by writing or texting.
• • 2. Patients who are unable to consent for themselves.
• • 3. Patients with tracheostomy or continuous continuous positive airway pressure (CPAP) or BiPAP.
• • 4. Known clinical evidence of frontotemporal dementia.
• • 5. 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).
• • 6. Epilepsy with history of seizures
• • 7. Renal disease (creatinine clearance \<40 ml/min using the Cockraft and Gault equation)
• • 8. Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
• • 9. 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).
• • 10. 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).
• • 11. 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.
• • 12. 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
• • 13. Have a first degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or bipolar I disorder.