Authorised Therapeutic exploratory (Phase II) Anorexia Nervosa

The therapeutic potential of psilocybin in anorexia nervosa in young adults

EU CTIS ID: 2024-515163-63-00

What this study is testing

To evaluate the safety and tolerability of two doses of psilocybin (25 mg) one month apart, administered with psychological support in young adults (16-35 years) with anorexia nervosa (AN) compared to the standard Treatment as Usual (TAU).

  • Therapeutic exploratory (Phase II)

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

  • Anorexia Nervosa as defined by DSM-5.
  • Age 16-35
  • Ongoing stable contact with an outpatient psychiatric unit.
  • BMI >16.
  • Have experienced at least one period of remission (minimum BMI 17) followed by a relapse.

You likely can't join if

  • Psychosis, bipolar disorder or substance use disorder
  • Positive drug tests
  • Suicidal intent.
  • Allergy or intolerance to drug content.
  • Any other clinically significant medical condition that, in the investigator’s opinion, may pose a risk to the participant or interfere with study results.
  • Blood or needle phobia.
See the full eligibility criteria
Who can join
  • Anorexia Nervosa as defined by DSM-5.
  • Age 16-35
  • Ongoing stable contact with an outpatient psychiatric unit.
  • BMI >16.
  • Have experienced at least one period of remission (minimum BMI 17) followed by a relapse.
What rules you out
  • Psychosis, bipolar disorder or substance use disorder
  • Positive drug tests
  • Suicidal intent.
  • Allergy or intolerance to drug content.
  • Any other clinically significant medical condition that, in the investigator’s opinion, may pose a risk to the participant or interfere with study results.
  • Blood or needle phobia.
  • Unable to follow study protocol.
  • Presence of metal pieces in the body (contraindicated by fMRI).
  • Family history of psychosis or bipolar disorder.
  • Refusal of birth control during until primary endpoint.
  • Previous use of classical psychedelics
  • Ongoing medications that would interfere negatively with the study drug.
  • Cardiovascular conditions, epilepsy, diabetes mellitus

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, 0-17 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.