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Study on Apomorphine and Psilocybin for Recovery in Coma Patients with Acute 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 studying treatments for patients who are in a coma or have other consciousness disorders due to sudden brain injuries. The study will explore the use of two treatments: Apomorphine, which is a medication often used to treat Parkinson's disease, and Psilocybin, a compound found in certain mushrooms that is being researched for its potential effects on the brain. The purpose of the study is to determine the safety of these treatments in patients who are unresponsive and in the intensive care unit (ICU) due to acute brain injury.

During the study, patients will receive either Apomorphine or Psilocybin to see if these treatments can help improve their level of consciousness. Some patients may receive a placebo, which is a substance with no active medication, to compare the effects. The study will monitor how quickly patients wake up within 30 days and will also look at other factors like eye response and brain activity. The study aims to find the right dose that is safe for patients.

The trial will last for a period of time, with regular check-ups to assess the patients' progress. The researchers will also evaluate the patients' overall health and any potential side effects of the treatments. The goal is to gather information that could help improve recovery for patients with severe brain injuries in the future.

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 and is expected to remain unconscious for at least three days. The patient must be 18 years or older.

  2. Step 2

    Medication administration

    The study involves the administration of three medications: apomorphine hydrochloride hemihydrate, sodium chloride, and psilocybin. Apomorphine is given as a subcutaneous infusion, sodium chloride as an intravenous infusion, and psilocybin in capsule form taken orally.

    The dosage and frequency of these medications are determined as part of a dose escalation study to ensure safety. The specific dosages and administration schedules are adjusted based on the patient's response and safety assessments.

  3. Step 3

    Monitoring and evaluation

    Throughout the trial, the patient's response to the medications is closely monitored. This includes assessing the time to awakening within 30 days and evaluating pupillary function and neurovascular coupling at days 1 and 7.

    Additional evaluations include the clinical outcome at day 90, the number of days the patient is alive outside the ICU, and monitoring for any serious adverse reactions or events, both somatic and neuropsychiatric.

  4. Step 4

    Follow-up

    The trial is designed to continue until December 31, 2028. Follow-up assessments are conducted to gather data on the long-term effects and safety of the treatment regimen.

Who can join the trial?

4 criteria

  • The patient must be in a **coma** or have other disorders of consciousness due to a sudden brain injury, which can be from an accident (traumatic) or not from an accident (non-traumatic).
  • The patient must be in the **Intensive Care Unit (ICU)** and not responding to stimuli, either because of a brain injury or another serious medical or surgical condition that has caused a coma not induced by medication.
  • The patient's **unconsciousness** is expected by the doctors to last for 3 days or more.
  • The patient must be **18 years old or older**.

Who cannot join the trial?

4 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 do not have an **acute brain injury**. This means a recent and sudden injury to the brain.
  • Patients who are not in the **ICU** (Intensive Care Unit). This is a special hospital area for very sick patients who need close monitoring.
  • Patients who are not **unresponsive**. This means they do not react to things happening around them.
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Investigated drugs

  • Apomorphine

    is a medication used in this trial to help stimulate arousal and awareness in patients who are in a coma due to acute brain injury. It is being tested to find the right dose that is safe for these patients. Apomorphine works by affecting certain chemicals in the brain that are involved in movement and alertness.

  • Psilocybin

    is another medication being tested in this trial. It is known for its effects on perception and mood, and in this study, it is being used to see if it can help improve awareness and consciousness in comatose patients. The trial aims to determine a safe dose for use in patients with severe brain injuries.

What is already known about the treatment

  • Apomorphine

    Apomorphine is administered via injection or subcutaneous infusion. It is currently being studied in clinical trials for its potential to aid recovery in patients with consciousness disorders due to brain injury. The main therapeutic indication is to enhance arousal and awareness in comatose patients. At the molecular level, apomorphine acts as a dopamine receptor agonist, stimulating dopamine receptors in the brain. It is classified pharmacologically as a dopaminergic agent.

  • Psilocybin

    Psilocybin is typically administered orally, often in capsule form. It is under investigation in clinical trials for its potential to improve recovery in patients with consciousness disorders following brain injury. The primary therapeutic indication is to boost arousal and awareness in comatose patients. Psilocybin works by activating serotonin receptors in the brain, particularly the 5-HT2A receptor, which may influence mood and perception. It is classified as a psychedelic compound.

Investigated diseases

Coma and other disorders of consciousness due to acute traumatic and non-traumatic brain injury – This condition involves a state of prolonged unconsciousness where a person is unresponsive to their environment. It can result from severe head trauma or other types of brain injury, leading to a disruption in normal brain function. The progression of this condition can vary, with some individuals remaining in a coma for a short period, while others may experience longer durations of unconsciousness. During this state, the person does not exhibit voluntary movements or responses to external stimuli. Over time, some patients may transition to other states of altered consciousness, such as a vegetative state or minimally conscious state. The recovery process can be unpredictable and depends on the extent and location of the brain injury.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-503617-30-02Estimated enrolment384 patientsSponsorRegion Hovedstaden

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