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Study on Psilocybin and Apomorphine for Improving Consciousness in Patients with Coma and Brain Injury

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What is this trial about?

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

This clinical trial is focused on patients who are in a coma or have other disorders of consciousness due to sudden or non-sudden brain injuries. The study aims to explore whether two treatments, psilocybin and apomorphine, can help improve the level of consciousness in these patients. Psilocybin is a compound found in certain mushrooms, and apomorphine is a medication that can affect brain activity. Both treatments will be given in specific forms: psilocybin as capsules and apomorphine as a solution for infusion.

The purpose of the study is to see if these treatments can help patients become more aware and responsive. During the study, some patients will receive psilocybin, some will receive apomorphine, and others may receive a placebo. The study will observe changes in consciousness levels within a few hours after treatment. The study will also look at other factors like how the pupils react to light and brain activity over a week, as well as the overall health outcome after 90 days.

Participants in the study will be monitored closely to ensure their safety, and any serious side effects will be recorded. The study is expected to continue until the end of 2028, with recruitment starting in early 2024. This research hopes to find new ways to help patients recover from severe brain injuries and improve their quality of life.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the patient is clinically unresponsive due to a brain injury or a systemic condition causing a coma, with unconsciousness expected to last for at least three days. The patient must be 18 years or older.

  2. Step 2

    Medication administration

    The patient receives a single dose of oral psilocybin in the form of PEX010 Psilocybin Capsules, containing 25 mg of psilocybin. This is administered to evaluate its effect on improving consciousness levels.

    In some cases, apomorphine hydrochloride hemihydrate is administered subcutaneously as an infusion to further assess its impact on consciousness. The specific dosage and frequency are determined by the study protocol.

  3. Step 3

    Monitoring and evaluation

    The patient's consciousness levels are monitored within 3 to 6 hours after medication administration. This is measured using a composite score that includes the FOUR score and SECONDs.

    Additional evaluations include pupillary function and neurovascular coupling, which are assessed using pupillometry and NIRS-EEG, respectively. These assessments occur on days 1 and 7 of the trial.

  4. Step 4

    Follow-up assessments

    The patient's clinical outcome is evaluated on day 90 using the GOS-E scale, which measures recovery levels.

    The number of days the patient is alive outside the ICU is recorded, along with any serious adverse reactions or events that occur during the trial.

Who can join the trial?

3 criteria

  • The patient must be in a state where they do not respond to stimuli, which means they are not reacting to things around them. This condition should be due to a brain injury, which can be caused by an accident (traumatic) or other reasons (non-traumatic), or due to a medical or surgical condition that leads to a coma not caused by medication.
  • The doctors expect the patient's unconscious state to last for at least 3 days.
  • The patient must be 18 years old or older.

Who cannot join the trial?

5 criteria

  • Patients who are not in a coma or do not have other disorders of consciousness. A coma is a state where a person is unconscious and cannot be awakened.
  • Patients who have not experienced a brain injury. A brain injury can be caused by a hit to the head or other reasons that affect the brain's function.
  • Patients who are not within the specified age range. The study is only for certain age groups.
  • Patients who do not belong to the specified clinical trial group. This means the study is looking for people with specific characteristics or conditions.
  • Patients who are not part of the vulnerable population selected for the study. Vulnerable populations may include groups like children or the elderly who need special consideration.
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Investigated drugs

  • Psilocybin

    is a substance that is being studied for its potential to improve consciousness levels in patients who are in a coma. It is known for its effects on the brain, which may help stimulate awareness and arousal, potentially aiding in recovery.

  • Apomorphine

    is a medication that is being tested for its ability to enhance consciousness in comatose patients. It works by affecting certain chemicals in the brain, which might help improve the patient's level of awareness and responsiveness.

What is already known about the treatment

  • Psilocybin

    Psilocybin is administered orally, typically in capsule form. It is currently being studied in clinical trials for its potential to enhance recovery in patients with consciousness disorders, such as coma, due to brain injury. The main therapeutic indication is to improve levels of consciousness. At the molecular level, psilocybin works by activating serotonin receptors in the brain, which may influence mood and perception. It is classified as a psychedelic compound.

  • Apomorphine

    Apomorphine is usually administered via subcutaneous injection. It is being explored in clinical trials for its ability to aid recovery in patients with consciousness disorders following brain injury. The primary therapeutic indication is to enhance consciousness levels. Apomorphine acts by stimulating dopamine receptors, which can affect motor control and alertness. It is classified as a dopamine agonist.

Investigated diseases

Coma and other disorders of consciousness due to acute traumatic and non-traumatic brain injury – This condition involves a state of profound unconsciousness where a person is unresponsive to their environment. It can result from severe head injuries or other factors that affect brain function. In a coma, the individual does not exhibit wakefulness or awareness, and they cannot be awakened by any stimulation. Disorders of consciousness can vary in severity, ranging from a minimally conscious state to a vegetative state. These conditions can evolve over time, with some individuals regaining varying levels of consciousness. The progression depends on the extent and location of the brain injury.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-503617-30-01Estimated enrolment384 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

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