Status:
NOT_YET_RECRUITING
Safety, Therapeutic Potential, and Mechanisms of Two Psilocybin Doses, Administered With Psychological Support in Young Adults With Anorexia Nervosa
Lead Sponsor:
Region Skane
Collaborating Sponsors:
Sten Theanders fond
Lions Forskningsfond Skåne
Conditions:
Anorexia Nervosa
Eligibility:
All Genders
16-35 years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to learn if psilocybin, given with psychological support, is safe and helps treat anorexia nervosa in young adults. Anorexia nervosa is a serious eating disorder tha...
Detailed Description
Background and Rationale Anorexia Nervosa (AN) is one of the most lethal psychiatric disorders, with mortality rates approximately five times higher than that of the general population. AN affects mul...
Eligibility Criteria
Inclusion
- Diagnosis of AN per DSM-5
- Have experienced at least one period of remission (minimum BMI 17) followed by a relapse
- Age 16-35
- BMI \>16
- Stable contact with a psychiatric unit
- Ability to provide informed consent
Exclusion
- Psychosis, bipolar disorder, substance use disorder, family history of psychosis or bipolar disorder, refusal of birth control, lifetime psychedelic use, unable to washout ongoing medications\* that would interfere negatively with the study drug
- Cardiovascular conditions
- Resting systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg at screening or baseline
- Clinically significant arrhythmias, tachycardia and QT prolongation
- History of stroke, myocardial infarction, or other significant cardiovascular events
- Seizure disorders or history of epilepsy
- Diabetes mellitus, positive drug tests, suicidal intent, allergy or intolerance to drug content, blood or needle phobia
- Only for the MRI-part of the study: Metal pieces in the body (contraindicated by fMRI, assessed in each case by MR-technician). Non-compliance to fMRI will not lead to study exclusion
- Any other clinically significant medical condition that, in the investigator's opinion, may pose a risk to the participant or interfere with study results
- Care under the Swedish Compulsory Psychiatric Care Act (LPT)
- 5-HT2A-antagonist need two weeks washout
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07169747
Start Date
October 1 2025
End Date
October 1 2027
Last Update
September 26 2025
Active Locations (1)
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1
Psykiatrikliniken, Baravägen 1
Lund, Sweden, 22240