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Effect of dry extract from Psilocybe cubensis (15‑25:1), extraction solvent methanol, with psychotherapy versus basic support on depressive symptoms in adults with depression

Verified siteInvestigationalNo placebo
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What is this trial about?

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

The study focuses on adults with Depression. It tests a single oral dose of PEX010, a capsule containing 25 mg of psilocybin. Participants receive the medication together with either structured psychotherapy (a series of guided talk sessions) or a simpler form of basic support that provides minimal counseling.

The aim is to see whether the combination of the medication and psychotherapy leads to greater improvement in mood compared with the medication plus basic support or with the usual treatment that patients normally receive (standard of care). Volunteers will attend an initial screening, take the capsule in a comfortable setting, meet with a therapist for several sessions, and then return for regular check‑ins over the next year to monitor mood, sleep and overall well‑being. Terms such as “psychotherapy” refer to professional talk therapy that helps people process thoughts and feelings, while “basic support” means brief guidance without the full therapeutic program.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    After agreeing to join, sign a consent form that explains the study and possible risks.

    Provide basic health information and confirm diagnosis of depression.

  2. Step 2

    Baseline assessment

    Complete initial questionnaires that measure mood, anxiety, and quality of life.

    Undergo a brief medical check and optional blood sample for future analysis.

  3. Step 3

    Assignment to treatment group

    Be placed in either the psychotherapy group or the basic support group.

    The study staff will not disclose the reason for the assignment.

  4. Step 4

    Psilocybin dose administration

    Receive one capsule containing 25 mg of psilocybin (dry extract from psilocybe cubensis).

    Take the capsule by mouth under direct supervision in a comfortable setting.

    The dose is given only once during the trial.

  5. Step 5

    Psychotherapy sessions (if assigned)

    Attend weekly therapeutic meetings lasting about 60 minutes for four weeks after the dose.

    The therapist helps process thoughts and emotions that arise during the experience.

  6. Step 6

    Basic support contacts (if assigned)

    Receive brief check‑in calls or visits lasting 15–30 minutes during the same four‑week period.

    The purpose is to provide reassurance and answer safety questions.

  7. Step 7

    Follow‑up assessments

    Complete the same mood questionnaires at weeks 2, 4, 10, 26, and 52 after the dose.

    Report any side effects, changes in mood, or new health concerns at each visit.

    Optional blood samples may be taken at the same time points.

  8. Step 8

    Study completion

    After the week‑52 visit, the study ends and all study data are collected.

    Receive a summary of overall study findings if desired.

Who can join the trial?

6 criteria

  • Informed oral and written consent: you must agree to join the study after the researchers explain what will happen, both by talking with you and by giving you a written document to sign.
  • Diagnosis of moderate‑severe major depressive disorder (MDD) according to the International Classification of Diseases 10 (ICD‑10) and the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM‑5): you need to have a doctor‑confirmed diagnosis of depression that is considered moderate to severe using these standard guidelines.
  • MADRS score between 20 and 60: you must have a total score on the Montgomery‑Åsberg Depression Rating Scale (MADRS) that falls in this range, which indicates a moderate to severe level of depressive symptoms.
  • Age 18 years or older: you must be at least 18 years old.
  • Willingness to avoid other psychotherapy or antidepressant medication until at least the 6‑week primary endpoint: you must agree not to receive any other talk therapy or take antidepressant drugs during the first six weeks of the study.
  • Having an identified support person: you need to have a trusted individual (such as a family member or friend) who can provide help and support during the study.

Who cannot join the trial?

18 criteria

  • Having a diagnosis of mental retardation, schizophrenia, other psychotic disorders, or bipolar disorder according to the official ICD-10 classification system.
  • Taking medicines that affect the body’s handling of substances through uridine diphosphate (UDP) or glucuronosyltransferase (UGT) enzymes.
  • Using any serotonergic psychedelic drug (a drug that changes mood by affecting serotonin) within the past 10 years or more than 25 times in a lifetime.
  • Having any cardiovascular disease, such as a past heart attack (myocardial infarction), chest pain from reduced blood flow (angina pectoris), severe heart failure (New York Heart Association class III or higher), or a prolonged heart‑electric interval (QTc longer than 450 ms for men or 470 ms for women).
  • Having uncontrolled high blood pressure (hypertension) with a systolic reading above 150 mm Hg or a diastolic reading above 90 mm Hg.
  • Being a female who can become pregnant and who is currently pregnant, breastfeeding, plans to become pregnant in the next 12 weeks, or does not use a highly effective method of birth control (such as hormonal pills, implants, intrauterine devices, partner’s vasectomy, or complete sexual abstinence) for the whole study period.
  • Having a positive pregnancy test (blood level of the hormone human chorionic gonadotropin (hCG) greater than 3 U/L) at the start of the trial.
  • Being allergic or having a strong reaction (hypersensitivity) to the study drug or any of its inactive ingredients (excipients).
  • Being unable to speak or understand Danish.
  • Having any other health condition that the study doctor believes would make participation unsafe or interfere with the study.
  • Showing any psychotic symptoms related to depression (such as hearing voices or having false beliefs).
  • Having a close family member (parent or sibling) with a history of psychotic disorders or bipolar disorder.
  • Having another psychiatric condition that could make the use of psilocybin unsafe, such as difficulty building a trusting relationship with study staff.
  • Meeting the criteria for a substance use disorder or an alcohol use disorder.
  • Having a history of suicide attempt or currently having strong thoughts of suicide, including any of the following: intent to act without a specific plan, a specific plan with intent, a score of 5 or higher on the suicidal thoughts item of the MADRS questionnaire, or any suicidal thoughts that the study team judges to pose a serious risk.
  • Having a serious neurological condition, such as epilepsy or a head injury that caused you to lose consciousness for more than 30 minutes.
  • Currently receiving treatments for depression other than the study drug, such as antidepressant medications, electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation. (Use of sleep medicines or benzodiazepines is allowed except on the day of dosing.)
  • Being in the process of stopping antidepressants or other serotonin‑affecting medicines without having waited at least five times the drug’s elimination half‑life.
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Investigated drugs

Psilocybin Capsules are oral capsules that contain a dry extract from the mushroom Psilocybe cubensis. In the study participants swallow the capsule to receive a psychedelic substance that is being tested for its ability to reduce symptoms of depression.

Psychotherapy is a series of guided talk sessions with a trained therapist. The therapist helps participants explore their thoughts, feelings, and experiences, especially those that arise after taking the psilocybin, to support emotional healing and lasting improvement in mood.

Basic support provides simple, non‑therapeutic assistance such as monitoring, safety checks, and general encouragement. It does not involve formal counseling, allowing researchers to compare the effects of psilocybin when paired with minimal versus more intensive psychological help.

Standard of care refers to the usual treatments that doctors normally prescribe for depression, which may include typical antidepressant medications, counseling, or other accepted interventions. This serves as a reference point to see how the psilocybin‑based approaches compare to everyday practice.

What is already known about the treatment

PEX010 Psilocybin Capsules (25mg psilocybin) - Orally taken as a capsule, the 25 mg dose delivers a dry extract of Psilocybe cubensis mushrooms. The product is currently investigational and is being studied in clinical trials; it is not yet approved for routine medical use. It is being tested for treating depression, aiming to reduce depressive symptoms. Psilocybin works by briefly increasing activity at serotonin receptors, especially the 5‑HT2A type, which changes mood and perception, and it is classified as a serotonergic psychedelic (a tryptamine).

Investigated diseases

Depression - a mood disorder marked by ongoing sadness, loss of interest in activities, and low energy. It often begins slowly and can become more intense over weeks or months if it continues. People may notice changes in sleep, appetite, concentration, and feelings of worthlessness. Symptoms can vary day to day, with some periods feeling slightly better and others feeling worse. The condition influences daily life, work, and relationships.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522961-31-01Estimated enrolment180 patientsSponsorKoebenhavns Universitet

sourced from the EU Clinical Trials Register and site verification

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