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Boosting recovery through excitation of arousal and awareness in comatose patients: Dose finding study (BREA2KTHROUGH DOSEFINDER)
EU CTIS ID: 2023-503617-30-02
What this study is testing
To do a dose escalation study to establish the safety of utilizing apomorphine and psilocybin in unresponsive ICU patients with acute brain injury. This is a prospective, open-label, phase 1b, dose escalation study (n=80 patients, i.e., 26 patients with 1 mg psilocybin, 27 patients with 10 mg, and 27 patients with 25 mg psilocybin; all 80 patients receive apomorphine 1-2h after psilocybin administration). The study is authorized and registered as EU-CT 2023-503617-30-02 and is currently recruiting patients as of June 2026. NB: The earlier version EU-CT 2023-503617-30-01 referred to under “Justification for trial category” was subsequently modified after request from the Ethics committee.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Fluent in Danish or English language
- Admission to ICU for severe acute brain injury after trauma, a cerebrovascular accident or anoxic-ischemic/metabolic injury (typically after cardiac arrest) causing coma or another acute DoC (i.e., UWS/VS, MCS), diagnosed by trained investigators
- Unconsciousness is expected by the attending physicians to last for ≥3 days
- Written informed consent for trial participation from both the trial guardian and next-of-kin
You likely can't join if
- Ongoing infusion of sedatives/continuous pharmacological sedation (We aim for unsedated patients during neurological examinations, pupillometry and NIRS-EEG, but if patients cannot fully be weaned from sedation, dosages are reduced to the lowest possible level.)
- Lack of Danish or English language proficiency
- Lack of next-of-kin consent
- Residency outside of Denmark
- Expected survival <7 days
- Known severe psychotic disorder (e.g., schizophrenia, psychosis after drug abuse, psychotic major depression, current major depression, bipolar disease, but previous history of major depression without psychosis allowed) or a history of a first-degree relative with such a disorder
See the full eligibility criteria
- Age ≥ 18 years
- Fluent in Danish or English language
- Admission to ICU for severe acute brain injury after trauma, a cerebrovascular accident or anoxic-ischemic/metabolic injury (typically after cardiac arrest) causing coma or another acute DoC (i.e., UWS/VS, MCS), diagnosed by trained investigators
- Unconsciousness is expected by the attending physicians to last for ≥3 days
- Written informed consent for trial participation from both the trial guardian and next-of-kin
- Ongoing infusion of sedatives/continuous pharmacological sedation (We aim for unsedated patients during neurological examinations, pupillometry and NIRS-EEG, but if patients cannot fully be weaned from sedation, dosages are reduced to the lowest possible level.)
- Lack of Danish or English language proficiency
- Lack of next-of-kin consent
- Residency outside of Denmark
- Expected survival <7 days
- Known severe psychotic disorder (e.g., schizophrenia, psychosis after drug abuse, psychotic major depression, current major depression, bipolar disease, but previous history of major depression without psychosis allowed) or a history of a first-degree relative with such a disorder
- Deafness, blindness, or bilateral eye surgery before the onset of brain injury
- Ongoing use of dopamine agonists or antagonists within 6 half-lives of the drug
- Ongoing or previous use of psychoactive or psychotropic substances (including, but not limited to monoamine oxidase inhibitors or medications that are known as uridine diphosphate glucuronosyltransferase enzyme modulators; and ongoing treatments with selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitors medications because of the potential to increase the risk of serotonin syndrome) 2 weeks prior examination or within 6 half-lives of the drug
- Cardiac valvular disease and pulmonal hypertension (for a theoretical concern that serotonergic agents might aggravate these conditions)
- Recovery of the ability to follow commands consistently prior to enrolment
- Females of childbearing potential, unless negative HCG test is
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.