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Clinical Trials/ACTRN12623000357651
ACTRN12623000357651
Not yet recruiting
Phase 1

A clinical trial to assess safety and efficacy of psilocybin-assisted psychotherapy for treatment-resistant anorexia nervosa in adults

niversity of Sydney0 sites30 target enrollmentApril 6, 2023

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Anorexia Nervosa
Sponsor
niversity of Sydney
Enrollment
30
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 6, 2023
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • Female patients aged 21\+ years
  • Meet criteria for AN as per DSM\-5 criteria
  • BMI greater than or equal to 14kg/m2
  • \> 3 years of illness duration
  • Current/ past treatments have not maintained remission
  • Referral from care team (psychiatrist or GP and clinician)
  • Agree to maintain contact with their care team
  • Identified support person
  • Agree to refrain from psychoactive drugs, nutritional or herbal supplements for at least 24 hours before each dose of psilocybin
  • Agree to a washout serotonergic medications if currently prescribed

Exclusion Criteria

  • History of neurological conditions (e.g. epilepsy)
  • Schizophrenia or other psychotic disorders/bipolar disorder
  • First or second degree relative with psychotic disorder
  • Severe dissociative disorders e.g.
  • Cardiovascular disease
  • Uncorrected hypo\- or hyperthyroidism
  • Abnormal serum electrolytes
  • Raised cardiac enzymes
  • Abnormal QT interval prolongation at screening or history of this
  • Hypertension

Outcomes

Primary Outcomes

Not specified

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