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Study of psilocybin compared to personalized rTMS treatment in adults with treatment-resistant depression

Fast replyInvestigationalNo 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 treating people with Treatment Resistant Depression (TRD), a condition where depression symptoms persist despite trying at least two different antidepressant medications. The study will compare two different treatments: psilocybin capsules (PEX010) and personalized brain stimulation therapy called repetitive Transcranial Magnetic Stimulation (rTMS). The purpose is to determine if psilocybin treatment works as effectively as personalized rTMS for people with treatment-resistant depression.

During the study, participants will receive either PEX010 psilocybin capsules containing 25 milligrams of the active substance or a placebo containing maltodextrin. The maximum treatment period with psilocybin is three weeks, with a total maximum dose of 50 milligrams. The study will monitor changes in depression symptoms and overall mental health for 60 days after starting treatment.

The research will use various methods to track participants' progress, including assessments of depression severity, anxiety levels, and general mental well-being. Brain activity will be monitored using special imaging techniques called functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) to understand how these treatments affect brain networks involved in depression.

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 assessment

    You will undergo an evaluation to confirm your diagnosis of Treatment Resistant Depression (TRD)

    Your medical history will be reviewed to verify previous treatments with at least two antidepressant medications

    Your current depression severity will be measured using the Montgomery-Asberg Depression Rating Scale (MADRS)

  2. Step 2

    Treatment assignment

    You will be assigned to receive either psilocybin capsules or personalized rTMS treatment

    If assigned to psilocybin group, you will receive 25mg psilocybin capsules taken by mouth

    The capsules contain an extract from psilocybe cubensis mushrooms

  3. Step 3

    Treatment period

    Your treatment will be monitored for 60 days

    Regular assessments will track changes in your depression symptoms

    Additional evaluations will measure anxiety, mood changes, and thinking abilities

  4. Step 4

    Brain imaging

    You will undergo brain scanning procedures:

    Functional magnetic resonance imaging (fMRI) to observe brain activity patterns

    Electroencephalography (EEG) to measure electrical activity in the brain

  5. Step 5

    Final evaluation

    After 60 days, your depression symptoms will be measured again

    The effectiveness of the treatment will be determined by checking if your MADRS score has decreased by 50% or more

    Additional assessments will evaluate changes in anxiety, mood, and overall health status

Who can join the trial?

6 criteria

  • Must be between 18 and 65 years old
  • Must be diagnosed with Treatment Resistant Depression (TRD), which means depression that has not improved after trying at least two different antidepressant medications
  • Must have taken previous antidepressant medications at proper doses for at least 4-6 weeks each
  • Can be either male or female
  • Must have been diagnosed with Major Depressive Disorder (MDD), which is a medical term for clinical depression
  • Must not belong to any vulnerable population groups (such as prisoners or persons unable to give consent)

Who cannot join the trial?

14 criteria

  • Current diagnosis of bipolar disorder (a mental health condition that causes extreme mood swings)
  • History of psychotic disorders (conditions that affect how your brain processes information)
  • Current substance use disorder (problematic pattern of using alcohol or drugs)
  • Severe medical conditions that are not well-controlled
  • Previous adverse reactions to similar treatments
  • Pregnant women or those planning pregnancy during the study period
  • Currently taking medications that could interact with study treatments
  • Participation in other clinical trials within the past 30 days
  • History of seizures or epilepsy (conditions causing unusual electrical activity in the brain)
  • Presence of metal implants in the head area (excluding dental fillings)
  • Unstable medical conditions that could affect brain function
  • Unable to commit to all required study visits and procedures
  • History of serious suicide attempts in the past 6 months
  • Cognitive impairment that could interfere with providing informed consent
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Investigated drugs

  • Psilocybin

    is a naturally occurring psychedelic compound that has shown promise in treating depression. When used in a controlled medical setting, it may help people with treatment-resistant depression by affecting brain chemistry and potentially providing new perspectives on their condition. The treatment is administered under careful medical supervision in a supportive environment.

  • Repetitive Transcranial Magnetic Stimulation (rTMS)

    is a non-invasive therapy that uses magnetic pulses to stimulate specific areas of the brain. This personalized treatment involves placing a magnetic coil against the scalp to deliver magnetic pulses that can help improve mood and reduce depression symptoms. The therapy is customized for each patient based on their individual brain patterns and does not require anesthesia or medication.

What is already known about the treatment

  • Psilocybin

    A naturally occurring psychedelic compound administered orally in controlled clinical settings as an investigational treatment for Treatment Resistant Depression (TRD). This substance works by binding to serotonin receptors in the brain, particularly 5-HT2A receptors, leading to altered neural connectivity patterns and potential therapeutic benefits in mood regulation. Currently undergoing rigorous clinical trials to evaluate its effectiveness as an alternative treatment for patients who haven't responded to conventional antidepressant medications, psilocybin belongs to the class of serotonergic psychedelics and is being studied for its ability to promote neuroplasticity and emotional processing.

  • rTMS (Repetitive Transcranial Magnetic Stimulation)

    A non-invasive brain stimulation technique that uses magnetic pulses delivered through a coil placed on the scalp to modulate neural activity in specific brain regions associated with depression. This treatment works by generating magnetic fields that can pass through the skull to stimulate nerve cells in targeted brain areas, particularly the dorsolateral prefrontal cortex, which is often underactive in depression. Currently approved by medical authorities for treating depression, rTMS belongs to the category of neuromodulation therapies and is being investigated as a personalized approach for patients with Treatment Resistant Depression.

Investigated diseases

Treatment-Resistant Depression - A complex form of major depressive disorder that does not respond adequately to at least two different antidepressant treatments. The condition is characterized by persistent feelings of sadness, loss of interest in activities, changes in sleep and appetite, and difficulty concentrating. People with this condition experience depressive symptoms that continue despite various intervention attempts. The disorder can significantly affect daily functioning, including work performance, relationships, and overall quality of life. Physical symptoms may include unexplained aches, pains, and fatigue that persist over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519844-34-03Estimated enrolment68 patientsSponsorUniversita' Degli Studi G. D'Annunzio Di Chieti

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).