Ongoing Clinical Trials for Altered State of Consciousness
There are currently 2 ongoing clinical trials exploring treatments for patients with altered states of consciousness due to acute brain injury. These studies are investigating the use of psilocybin and apomorphine to potentially improve consciousness levels in coma patients in intensive care settings.
Clinical trial locations
- Denmark
Study on Apomorphine and Psilocybin for Recovery in Coma Patients with Acute Brain Injury
This trial is investigating new treatment approaches for patients who are in a coma or experiencing other consciousness disorders following sudden brain injuries. The study takes place in Denmark and focuses on two investigational medications that may help improve recovery.
Who can participate:
- Adults aged 18 years or older
- Patients in the Intensive Care Unit who are unresponsive due to brain injury or another serious medical condition causing coma (not medication-induced)
- Patients whose unconsciousness is expected by doctors to last for 3 days or more
- Patients with coma or consciousness disorders caused by traumatic (accident-related) or non-traumatic brain injury
Who cannot participate:
- Patients who are not in a coma or do not have disorders of consciousness (a state where a person is unconscious and cannot be awakened)
- Patients without a recent and sudden brain injury
- Patients not in the ICU
- Patients who are responsive to their environment
What the trial involves:
The study explores two investigational drugs. Apomorphine, a medication commonly used for Parkinson’s disease, works by affecting dopamine receptors in the brain, which are involved in movement and alertness. In this trial, apomorphine is given through subcutaneous infusion to stimulate arousal and awareness in comatose patients.
Psilocybin, a compound found in certain mushrooms, is administered orally in capsule form. It activates serotonin receptors in the brain, which may influence mood and perception. The trial aims to determine if psilocybin can help improve consciousness and awareness in patients with severe brain injuries.
During the study, patients receive either apomorphine or psilocybin, while some may receive a placebo for comparison. The research team monitors how quickly patients wake up within 30 days and evaluates factors such as eye response and brain activity. The study is designed as a dose escalation trial to find the safest and most effective dosage.
Follow-up assessments continue until December 31, 2028, including monitoring at days 1, 7, and 90 to assess recovery progress, time spent alive outside the ICU, and any potential side effects, both physical and neuropsychiatric.
Study on Psilocybin and Apomorphine for Improving Consciousness in Patients with Coma and Brain Injury
This second trial, also conducted in Denmark, similarly explores whether psilocybin and apomorphine can help improve consciousness levels in patients with brain injury-related coma. The study aims to find new ways to help these patients become more aware and responsive.
Who can participate:
- Adults aged 18 years or older
- Patients who do not respond to stimuli due to traumatic or non-traumatic brain injury, or due to a medical or surgical condition causing coma (not medication-induced)
- Patients whose unconscious state is expected to last for at least 3 days
Who cannot participate:
- Patients not in a coma or without consciousness disorders
- Patients who have not experienced a brain injury
- Patients outside the specified age range
- Patients who do not meet the specific trial characteristics being studied
What the trial involves:
Patients in this study receive a single dose of psilocybin in capsule form (25 mg) to evaluate its effect on improving consciousness. Psilocybin works by activating serotonin receptors in the brain, particularly the 5-HT2A receptor, which may help enhance awareness.
Some patients may also receive apomorphine administered through subcutaneous infusion. Apomorphine stimulates dopamine receptors, potentially improving motor control and alertness in comatose patients.
The research team closely monitors consciousness levels within 3 to 6 hours after medication administration using specialized scoring systems. Additional evaluations include pupillary function tests and brain activity monitoring on days 1 and 7. The patient’s overall recovery is assessed at day 90 using a standardized scale, and the number of days spent alive outside the ICU is recorded.
Both treatments are carefully monitored for safety, with any serious adverse reactions documented throughout the trial. The study is expected to continue recruitment until the end of 2028.
Summary
Both clinical trials are taking place in Denmark and represent innovative research approaches to treating severe consciousness disorders following brain injury. The trials share similar investigational drugs—psilocybin and apomorphine—though they differ slightly in their administration protocols and assessment timelines.
These studies focus on a highly vulnerable patient population in intensive care settings, exploring whether medications traditionally used for other conditions (apomorphine for Parkinson’s disease) or emerging therapeutic compounds (psilocybin) might help restore consciousness in coma patients. Both trials emphasize careful dose-finding and comprehensive safety monitoring, recognizing the critical nature of treating patients with severe brain injuries.
The concentration of both trials in Denmark reflects that country’s research focus on consciousness disorders. The extended follow-up period until 2028 demonstrates a commitment to understanding long-term outcomes and safety profiles of these novel treatment approaches.