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A study on the effects of support and music during psilocybin therapy for people 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

This study focuses on Depression, a condition that affects how a person feels, thinks, and handles daily activities. The research is designed to investigate the impact of support and music on the immediate and long-term effects of Psilocybin therapy. The treatment being tested is PEX010, which is provided in the form of Psilocybin Capsules containing a dried extract from a specific type of mushroom.

Participants in the study will take the medication orally. During the process, the use of music and professional support is evaluated to see how these elements influence the experience and the lasting effects of the treatment. The study monitors how symptoms change from the beginning of the process through a follow-up period of six weeks.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Administration of psilocybin

    An oral dose of 25 mg of PEX010 psilocybin capsules is taken. These capsules contain a dried extract from psilocybe cubensis, which is the active ingredient used during the session.

  2. Step 2

    Monitoring and follow-up

    Depressive symptoms are measured using a scale called MADRS, which is a tool used to assess the severity of depression. This measurement occurs at the 6-week follow-up mark to observe any changes in symptoms.

Who can join the trial?

6 criteria

  • You must agree to participate by providing both spoken and written consent, which means you officially say "yes" to being in the study.
  • You must be diagnosed with moderate-to-severe Major Depressive Disorder (MDD), which is a type of depression that significantly affects your daily life and mood, based on standard medical classification systems.
  • Your score on the MADRS scale, which is a tool doctors use to measure how severe your depression symptoms are, must be between 20 and 60.
  • You must be between 25 and 65 years old.
  • You must be willing to stop taking other antidepressant medications or participating in other psychotherapy (talk therapy) until at least 6 weeks after the main part of the study is finished.
  • You must have a support person, which is a trusted individual who can help and be there for you during the study.

Who cannot join the trial?

19 criteria

  • Having a diagnosis of mental retardation (intellectual disability), schizophrenia (a serious mental disorder affecting how a person thinks and perceives reality), psychotic disorders (conditions involving loss of contact with reality), or bipolar disorders (mood swings ranging from extremely high to extremely low).
  • Taking any medicine that affects uridine diphosphate (UDP) or glucuronosyltransferase (UGT), which are specific processes the body uses to break down and clear out substances.
  • Having used any serotonergic psychedelic drug (medicines that change brain chemicals and perception) more than 25 times in your life or at any time within the last 10 years.
  • Having cardiovascular disease (heart and blood vessel problems), such as a history of myocardial infarction (heart attack), angina pectoris (chest pain caused by reduced blood flow to the heart), or heart failure (a condition where the heart cannot pump enough blood).
  • Having a prolonged QTc interval, which means the electrical timing of your heartbeat is longer than normal.
  • Having uncontrolled hypertension, which is high blood pressure where the top number is higher than 150 or the bottom number is higher than 90.
  • Being a woman who is pregnant, breastfeeding, planning to become pregnant within the next 12 weeks, or not using highly effective contraception (methods used to prevent pregnancy, such as birth control pills, hormonal implants, or intrauterine devices).
  • Having a positive pregnancy test, defined as a level of human chorionic gonadotropin (hCG) (the hormone detected in pregnancy tests) higher than 3 U/L.
  • Having an hypersensitivity (an allergic reaction) to the main medicine used in the study or any of its excipients (inactive ingredients used to make the medicine).
  • Being unable to speak or understand the Danish language.
  • Having any other health condition that the study doctor believes would make it unsafe or difficult to participate.
  • Having psychotic symptoms as part of your depression, such as seeing or hearing things that are not there.
  • Having a close family member, such as a parent or sibling, with a history of psychotic disorders or bipolar disorders.
  • Having any other mental health condition that makes it unsafe to use psilocybin (the medicine being studied) or prevents you from building a trusting relationship with the staff.
  • Meeting the diagnosis for substance use disorder (addiction to drugs) or alcohol use disorders.
  • Having a history of suicide attempts or having active thoughts of suicidal ideation (thoughts of wanting to end your life), whether you have a specific plan or if the study staff believe you are at risk of harming yourself.
  • Having a severe neurological disease (a condition affecting the brain or nervous system), such as epilepsy (seizures) or a history of head trauma involving a loss of consciousness for more than 30 minutes.
  • Taking any current treatments for depression, such as pharmacotherapies (medicines), electroconvulsive therapy (seizure therapy), deep brain stimulation, or vagus nerve stimulation.
  • Currently reducing the dose of antidepressants or other serotonergic medications (drugs that affect serotonin in the brain). Any required medication must have been stopped for at least five elimination half-lives (the time it takes for half of the medicine to leave your body).
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Investigated drugs

Psilocybin is a substance derived from certain types of mushrooms that is given in capsule form to be swallowed. In this study, it is being tested to see how it affects people experiencing depression when combined with music and professional support.

What is already known about the treatment

PEX010 Psilocybin - This medication is taken orally in the form of capsules and is currently being studied in clinical trials for its potential to treat depression. It belongs to a class of substances known as psychedelics, which work by interacting with specific serotonin receptors in the brain to temporarily alter perception and mood. This process helps reorganize brain activity patterns, which may lead to long-lasting improvements in mental health.

Investigated diseases

Depression - This is a mental health condition characterized by persistent feelings of sadness and a loss of interest in activities once enjoyed. It can affect how a person thinks, feels, and handles daily activities such as sleeping, eating, or working. The condition often involves changes in energy levels and patterns of concentration. Over time, symptoms may become more frequent or intense, impacting a person's emotional stability. It can manifest through various psychological and physical changes that disrupt regular life functions.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522961-31-00Estimated enrolment120 patientsSponsorKoebenhavns Universitet

sourced from the EU Clinical Trials Register and site verification

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