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
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.
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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