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New treatment option for COPD (Chronic Obstructive Pulmonary Disease)
Official title Psilocybin Therapy for Psychological Distress in Palliative Patients
ClinicalTrials.gov ID: NCT06782724
What this study is testing
What is Psilocybin therapy?
Psilocybin therapy is an investigational medicine, being studied as a potential treatment for copd (chronic obstructive pulmonary disease).
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 goal of this clinical trial is to evaluate whether psilocybin therapy can effectively treat depression and psychological distress in adult patients with COPD, ALS, MS, or APD who have at least 6 months life expectancy. The main questions it aims to answer are: Can psilocybin therapy safely reduce depressive symptoms compared to low-dose control?
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Patient has to be diagnosed with one of the following four conditions, defined as: COPD i) Diagnosis by medical specialist ii) Postbronchodilator...
- Patient meets ICD-10 criteria for major depressive disorder documented through the com-pletion of the mood section of the Mini International...
- Patient has a MADRS score of \> 19.
- Patient should have a life expectancy of at least 6 months (assessed by study physician).
- Patient is at least 18 years of age.
You likely can't join if
- Patient has used a psychedelic substance in the past 6 months (e.g., psilocybin, LSD, 5-MeO-DMT, DMT, ayahuasca or mescaline).
- Patient is in active treatments for other psychiatric disorders, judged by the screening clinician to be a more significant clinical problem than...
- Patient meets ICD-10 criteria for schizophrenia spectrum or other psychotic disorders, including major depressive disorder with psychotic features...
- Patients with any lifetime diagnosis of schizophrenia spectrum or other psychotic disorders.
- Patient has a first-degree relative with schizophrenia spectrum, bipolar I disorder or other psychotic disorders (expect substance/medication-induced...
- Patients with a pre-existing psychiatric condition judged to be incompatible with safe exposure to psilocybin therapy.
See the full eligibility criteria
Who can join
- Patient has to be diagnosed with one of the following four conditions, defined as: COPD i) Diagnosis by medical specialist ii) Postbronchodilator FEV1/FVC \< 0,7 and FEV1 \<80% pred iii) ≥ 40 years old iv) ≥ 10 years...
- Patient meets ICD-10 criteria for major depressive disorder documented through the com-pletion of the mood section of the Mini International Neuropsychiatric Interview by a screen-ing psychologist or physician.
- Patient has a MADRS score of \> 19.
- Patient should have a life expectancy of at least 6 months (assessed by study physician).
- Patient is at least 18 years of age.
- Patient has an identified caregiver/support person. See specific conditions for Czechia in Appendix 5.
- Patient is able to read and understand the informed consent and all scales used in a local language. For those with ALS, MS, or APD, competency is ensured via neurologist assessment, cognitive screening, caregiver...
- Patient is able to and willing to adhere to study requirements, including attending all study visits, preparatory and follow-up sessions, and completing all study evaluations.
- Patient is able to ingest capsules.
What rules you out
- Patient has used a psychedelic substance in the past 6 months (e.g., psilocybin, LSD, 5-MeO-DMT, DMT, ayahuasca or mescaline).
- Patient is in active treatments for other psychiatric disorders, judged by the screening clinician to be a more significant clinical problem than depression / distress.
- Patient meets ICD-10 criteria for schizophrenia spectrum or other psychotic disorders, including major depressive disorder with psychotic features (except substance/medication-induced or due to another medical...
- Patients with any lifetime diagnosis of schizophrenia spectrum or other psychotic disorders.
- Patient has a first-degree relative with schizophrenia spectrum, bipolar I disorder or other psychotic disorders (expect substance/medication-induced or due to another medical condition).
- Patients with a pre-existing psychiatric condition judged to be incompatible with safe exposure to psilocybin therapy.
- Significant suicide risk as defined by (1) suicidal ideation with intent to act (defined as ≥ 5 on MADRS item 10), (2) suicidal attempts within the past year, or (3) clinical assessment of significant suicidal risk...
- Patient meets ICD-10 criteria for active/current alcohol or drug use disorder.
- Patient has ongoing treatment with antipsychotic drugs. Any prohibited agents must have been stopped at least 5x the elimination half-life of the specific drug at the time of baseline (see Appendix 1a for Prohibited...
- Patient is unwilling or unable to pause formal psychotherapy (days 0-42).
- Patient has neurological conditions (e.g., intracranial tumour, epilepsy, brain injuries, or other neurological disorders) expected by the PIs to conflict with the treatment / study protocol.
- Disease-specific exclusion criteria: COPD: Unresolved exacerbation or pulmonary infection within last 4 weeks. ALS: Significant cognitive deficits (MoCa, see below). MS: Significant cognitive deficits (MoCa, see below)...
- Cardiovascular conditions: recent stroke (\ 140/90 mmHg), clinically significant arrhythmia within 1 year of signing the ICF, or QTc prolongation exceeding 450ms (males) / 470ms (females).
- Patient has moderate to severe hepatic impairment (Child-Pugh score ≥ 7).
- Patient has insulin-dependent diabetes or who are taking oral hypoglycaemic agents and have a current risk of hypoglycaemia that would require medical intervention.
- Patient has any physical or psychological symptoms, medications, blood test results or clinically significant findings at Screening or Baseline (based on the clinical judgement of clinical/medical study personnel) that...
- Patient has an allergy or intolerance to any of the materials contained in either drug product.
- Cognitive and Neuropsychological assessment: Patients will be excluded if they score below mean minus 1.5 Standard Deviation according to normative age and scholarity adjusted data on the Montreal Cognitive Assessment...
- Recent (2 weeks) change or planned change in antidepressant medication during the intervention.
- Women who are pregnant, intend to become pregnant during the study or who are currently nursing, or are unwilling to use Highly Effective Contraceptive Methods
The study team makes the final eligibility decision.
Where it's taking place
- Prague, Czechia
- Copenhagen, Denmark
- Groningen, Provincie Groningen, Netherlands
- Lisbon, Portugal
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 - 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?
Study sites include Prague, Czechia; Copenhagen, Denmark; Groningen, Provincie Groningen, Netherlands; Lisbon, Portugal. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.