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Study of psilocybin therapy for psychological distress in patients with COPD, ALS, multiple sclerosis, or atypical Parkinson's disorders

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on testing psilocybin therapy in patients with several progressive conditions including Chronic Obstructive Pulmonary Disease (COPD), Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), and Atypical Parkinson Disorder (APD) who are experiencing psychological distress. The study will use different doses of psilocybin capsules (1 mg, 15 mg, and 25 mg) given by mouth to understand how this treatment might help reduce depression symptoms in these patients.

The purpose of this research is to evaluate whether medium to high doses of psilocybin therapy are safe and effective in reducing depression symptoms compared to low doses in patients with these conditions. Participants will receive two doses of the medication during the study, with evaluations of their depression symptoms occurring before treatment and six weeks after the second dose.

During the study, patients will be monitored for changes in their psychological well-being, including their ability to cope with end-of-life concerns, overall quality of life, and general mental health. The study will also look at how the treatment affects the stress levels and daily responsibilities of those caring for the patients. The treatment period will last approximately two months, with follow-up evaluations to track the participants' progress.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your mental health will be assessed using the Montgomery Åsberg Depression Rating Scale (MADRS)

    A medical specialist will confirm your diagnosis of COPD, ALS, MS, or atypical Parkinson disorder

    Your life expectancy must be at least 6 months, as determined by the study physician

  2. Step 2

    First medication session

    You will receive oral capsules containing psilocybin

    The dose will be either 1 mg (low dose) or 15-25 mg (medium/high dose)

    The capsules must be taken as directed by the medical staff

  3. Step 3

    Second medication session

    A second dose of psilocybin capsules will be administered

    The dosage will follow the same protocol as the first session

    The timing between doses will be determined by the medical staff

  4. Step 4

    Follow-up evaluation

    Six weeks after the second dose, your depression symptoms will be evaluated again

    The evaluation will use the same MADRS scale as the initial assessment

    Additional assessments will measure your quality of life and psychological well-being

  5. Step 5

    Study completion

    The study will conclude after the final evaluation

    Your participation will help assess how psilocybin therapy affects depression symptoms in patients with serious medical conditions

Who can join the trial?

18 criteria

  • Must have a confirmed diagnosis of one of these conditions: COPD (chronic lung disease), ALS (motor neuron disease), MS (multiple sclerosis), or APD (atypical Parkinson disorder)
  • Must be diagnosed with major depressive disorder confirmed through a specialized interview
  • Must score higher than 19 on the MADRS (a depression rating scale)
  • Must have a life expectancy of at least 6 months
  • Must be at least 18 years old
  • Must have an identified caregiver or support person
  • Must be able to read and understand consent forms in their local language
  • Must be willing to attend all study visits and complete all evaluations
  • Must be able to swallow capsules
  • For COPD patients specifically:
    • Must be 40 years or older
    • Must have at least 10 years smoking history
    • Must have specific breathing test results showing reduced lung function
    • For ALS patients:
      • Must meet specific Goldcoast criteria for ALS
      • Must have certain minimum scores on physical function tests
      • For MS patients:
        • Must meet revised McDonald criteria for MS diagnosis
        • Must have a minimum disability score of 1.0 on the EDSS scale
        • For APD patients:
          • Must have advanced to late-stage symptoms
          • Must show evidence of motor and non-motor fluctuations

Who cannot join the trial?

14 criteria

  • Personal or family history of schizophrenia, psychosis, or bipolar disorder (severe mental health conditions that affect mood, thinking and behavior)
  • Current diagnosis of major depressive disorder with psychotic features or treatment-resistant depression
  • History of suicide attempts in the past year or current suicidal thoughts with specific plans
  • Active substance abuse or dependence in the past 6 months (excluding nicotine)
  • Severe heart conditions or uncontrolled high blood pressure
  • Severe liver or kidney problems
  • Current use of medications that could interact with psilocybin, including certain antidepressants
  • Pregnancy, breastfeeding, or planning to become pregnant
  • Participation in other clinical trials within the past 30 days
  • History of adverse reactions to similar substances
  • Inability to provide informed consent
  • Conditions that might interfere with psychological therapy sessions
  • Unstable medical conditions that could pose safety risks during the trial
  • Severe cognitive impairment that would affect participation in therapy sessions
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Investigated drugs

Psilocybin is a naturally occurring psychedelic compound that is being studied as a potential therapy for psychological distress and depression. In this trial, it is being investigated as a treatment for patients with serious medical conditions (COPD, ALS, MS, or APD) who are experiencing depression. The therapy involves administering psilocybin in different doses along with psychological support to help patients process their experiences and potentially reduce their depressive symptoms.

What is already known about the treatment

Psilocybin - A naturally occurring psychedelic compound administered orally in controlled therapeutic settings for clinical research in treating psychological distress and depression in palliative care patients. The substance works by binding to serotonin receptors in the brain, particularly the 5-HT2A receptors, which can lead to altered mood, perception, and consciousness in ways that may help reduce psychological distress. Currently being studied in clinical trials for patients with conditions such as COPD, ALS, MS, and atypical Parkinson disorders, this compound belongs to the class of classical psychedelics and is being evaluated at different dosage levels to assess its safety and effectiveness in treating depression symptoms in seriously ill patients.

Investigated diseases

  • Chronic Obstructive Pulmonary Disease (COPD)

    A progressive lung condition that makes breathing difficult due to narrowed airways and damaged lung tissue. The airways become inflamed and thickened, while air sacs lose their elastic quality. This causes symptoms like shortness of breath, chronic cough, and excess mucus production.

  • Amyotrophic Lateral Sclerosis (ALS)

    A neurological condition affecting nerve cells that control voluntary muscle movement. The disease causes progressive weakness in muscles used for moving, speaking, eating, and breathing. Over time, the muscles become smaller and weaker as motor neurons degenerate.

  • Multiple Sclerosis (MS)

    A condition where the immune system affects the protective covering of nerve fibers in the central nervous system. This disruption of nerve signals can cause various symptoms including fatigue, difficulty walking, vision problems, and muscle weakness. The disease can progress in different patterns.

  • Multiple System Atrophy (MSA)

    A neurological disorder that affects multiple parts of the nervous system. It causes problems with movement, balance, and automatic body functions. Symptoms typically include poor coordination, fainting spells, and difficulties with speech and swallowing.

  • Progressive Supranuclear Palsy (PSP)

    A brain disorder that affects movement, balance, speech, and vision. The condition causes gradual deterioration of brain cells in specific areas. People experience difficulties with walking, balance, and eye movements.

  • Corticobasal Syndrome (CBS)

    A neurological condition affecting both movement and cognitive functions. It typically begins on one side of the body with stiffness, shakiness, and difficulty controlling arm or leg movements. The condition gradually affects both sides of the body and can impact speech and comprehension.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510488-36-01Protocol code18870Estimated enrolment108 patientsSponsorUniversitair Medisch Centrum Groningen

sourced from the EU Clinical Trials Register and site verification

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