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Tests treatment safety and results for Anorexia Nervosa
Official title Safety, Therapeutic Potential, and Mechanisms of Two Psilocybin Doses, Administered With Psychological Support in Young Adults With Anorexia Nervosa
ClinicalTrials.gov ID: NCT07169747
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for anorexia nervosa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 that currently has no approved medicine.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 35
You may be able to join if
- 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
You likely can't join if
- Psychosis, bipolar disorder, substance use disorder, family history of psychosis or bipolar disorder, refusal of birth control, lifetime psychedelic...
- 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
See the full eligibility criteria
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lund, Sweden
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, 16 years to 35 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lund, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.