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Trial registered on ANZCTR


Registration number
ACTRN12623000357651p
Ethics application status
Submitted, not yet approved
Date submitted
22/02/2023
Date registered
6/04/2023
Date last updated
26/05/2024
Date data sharing statement initially provided
6/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical trial of psilocybin-assisted psychotherapy for treatment-resistant anorexia nervosa
Scientific title
A clinical trial to assess safety and efficacy of psilocybin-assisted psychotherapy for treatment-resistant anorexia nervosa in adults
Secondary ID [1] 308116 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia Nervosa 327823 0
Condition category
Condition code
Mental Health 324902 324902 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will involve 3 oral doses of psilocybin embedded with psilocybin-assisted psychotherapy (talk therapy). Consisting of at least 1 face-to-face and 1 telehealth preparatory sessions (overall 6-8 hours) prior to first dose, supervision during 3 dosing sessions and 3-post dosing integration sessions.

Each participant will receive a total of three psilocybin sessions, each session spaced two weeks apart, with 1 mg in session 1 and 25 mg in sessions 2 and 3. Only the participant will be blind to dose, knowing only that they may receive maximum 25 mg in any session. Dosing sessions will last 6-8 hours and will be administered by a nurse practitioner and clinical psychologist.

Examples of specific content/topics that will be discussed during the dosing sessions will be specific to the participant. During dosing sessions contact is kept to a minimum to encourage participants to explore their own mental state.
Intervention code [1] 324570 0
Treatment: Drugs
Intervention code [2] 325772 0
Treatment: Other
Comparator / control treatment
Single blind

The 1mg dose of psilocybin is intended to act as a control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333739 0
Change in core eating disorder psychopathology by the Eating Disorder Examination and the Eating Disorder Examination-Questionnaire (EDE/EDE-Q)
Timepoint [1] 333739 0
It will be administered at baseline assessment, primary endpoint (6 weeks post-first dose), monthly follow-up to 6-months and a 12-month follow-up post-first dose.
Primary outcome [2] 333967 0
Effect of psilocybin-assisted psychotherapy on motivation to change. Measured by the Readiness and Motivation Questionnaire (RMQ).
Timepoint [2] 333967 0
Administered at baseline assessment, primary endpoint (6 weeks post-first dose), monthly follow-up to 6-months and 12-month follow-up post-first dose.
Secondary outcome [1] 418884 0
Evaluate effects on depression symptoms using the Beck-Depression Inventory (BDI-II)
Timepoint [1] 418884 0
Baseline assessment, remote monitoring, 6-week post-first dose, monthly up to 6 months and 12-month follow-up post-first dose
Secondary outcome [2] 418885 0
Evaluate effects on anxiety symptoms using the State-Trait Anxiety Inventory (STAI)
Timepoint [2] 418885 0
Baseline assessment, remote monitoring, 6-week post-first dose, monthly up to 6 months and 12-month follow-up post-first dose
Secondary outcome [3] 419928 0
Evaluate effects on obsessions and compulsions using the Yale-brown Cornell Eating Disorder Scale Self-Report (YBC-EDS-Self report)
Timepoint [3] 419928 0
Baseline assessment, 6-week post-first dose, monthly follow-up to 6-months and a 12-month follow-up post-first dose
Secondary outcome [4] 419929 0
Evaluate effects on quality of life using the Eating Disorders Quality of Life (EDQOL)
Timepoint [4] 419929 0
Baseline assessment, remote monitoring, 6-week post-first dose, monthly follow up to 6-months and 12-month follow-up post-first dose.
Secondary outcome [5] 419930 0
Evaluate effects on cognitive flexibility using the Cognitive Flexibility Scale (CFS)
Timepoint [5] 419930 0
Baseline assessment, remote monitoring, 6-weeks post-first dose, monthly follow-up to 6-months and 12-month follow-up post-first dose
Secondary outcome [6] 419931 0
Evaluate effects on inflexible adherence to rigid eating rules using the Inflexible Eating Questionnaire (IEQ).
Timepoint [6] 419931 0
Baseline assessment, remote monitoring, 6-weeks post-first dose, monthly follow-up to 6 months and 12-month follow-up post-first dose.
Secondary outcome [7] 419932 0
Evaluate effects on psychological flexibility using the Acceptance and Action Questionnaire (AAQ-2)
Timepoint [7] 419932 0
Baseline assessment, remote monitoring, 6-weeks post-first dose, monthly follow-up to 6 months and a 12 month follow-up post-first dose
Secondary outcome [8] 419933 0
Evaluate effects on mystical experiences using the Mystical Experiences Questionnaire (MEQ)
Timepoint [8] 419933 0
It will be administered at the end of psilocybin dosing session 1, 2 and 3.
Secondary outcome [9] 419934 0
Evaluate patient and clinical therapeutic relationship with the Scale to assess the therapeutic relationship - Clinician (STAR-C)
Timepoint [9] 419934 0
Baseline assessment and 6-week post-first dose
Secondary outcome [10] 420231 0
Evaluate patient and clinical therapeutic relationship with the Scale to assess the therapeutic relationship - Patient (STAR-P)
Timepoint [10] 420231 0
Baseline assessment and 6-week post-first dose
Secondary outcome [11] 420280 0
Safety of psilocybin-assisted psychotherapy. Psychological adverse events may include transient anxiety, paranoia, fear, panic and dysphoria which subside with psychological support or as drug effects subside. Common physical adverse effects with high doses of psilocybin include headaches which last for 1-2 days maximum, nausea, and moderate mild increases in blood pressure and heart rate.
Timepoint [11] 420280 0
Data regarding adverse events will be collected after each dosing session, during remote monitoring via telemedicine/telehealth with treating clinicians. Spontaneous reporting of adverse events will be encouraged with a medication card, providing the participant with the contact details.

Eligibility
Key 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
• Availability for the duration of the study
• Agree to have research team maintain contact with an identified next-of-kin or support person (i.e. close friend) for the duration of the study
• Capacity to consent
• Sufficiently competent in English and mental capacity to provide written informed consent.
Minimum age
21 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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.
• Diabetes
• Cardiovascular disease
• Uncorrected hypo- or hyperthyroidism
• Abnormal serum electrolytes
• Raised cardiac enzymes
• Abnormal QT interval prolongation at screening or history of this
• Hypertension
• Hepatic or renal failure (e.g., CrCl < 30ml/min)
• Drug or alcohol dependence in last 6 months
• Prior allergy, hypersensitivity or adverse reaction to psychedelic substances
• Emotionally unstable personality, or other psychiatric problem that may jeopardize therapeutic alliance or safety
• Currently an involuntary patient
• Patient being unsafe to manage on an outpatient basis
• History of serious suicide attempts or presence of a suicide/ serious self-harm risk at screening
• History of laxative abuse in the last 3 months
• Unstable physical condition (e.g., weight loss > 2 kg in the prior month)
• Pregnancy (negative pregnancy tests mandatory at screening visits, baseline, and psilocybin dosing sessions) or Nursing
• If sexually active, participants who lack appropriate contraception
• Patients currently or previously (past 3 months) enrolled in another clinical trial of an investigational product
• No email/phone.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 312371 0
Government body
Name [1] 312371 0
Department of Health, Medical Research Future Fund (MRFF) Innovative Therapies for Mental Illness Grant
Country [1] 312371 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 313937 0
None
Name [1] 313937 0
Address [1] 313937 0
Country [1] 313937 0
Other collaborator category [1] 282441 0
University
Name [1] 282441 0
Imperial College London
Address [1] 282441 0
2nd Floor Commonwealth Building
160 Du Cane Road
W12 0NN London
Country [1] 282441 0
United Kingdom

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311731 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 311731 0
Ethics committee country [1] 311731 0
Australia
Date submitted for ethics approval [1] 311731 0
10/04/2024
Approval date [1] 311731 0
Ethics approval number [1] 311731 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122166 0
Prof Sloane Madden
Address 122166 0
Ramsay Clinic Northside, 2 Frederick St, St Leonards NSW 2065
Country 122166 0
Australia
Phone 122166 0
+61 408272805
Fax 122166 0
Email 122166 0
sloane.madden@theredleafpractice.com
Contact person for public queries
Name 122167 0
Sarah-Catherine Rodan
Address 122167 0
University of Sydney, Level 6, Brain and Mind Centre, 94 Mallett Street, Camperdown, NSW, 2050
Country 122167 0
Australia
Phone 122167 0
+61 477222500
Fax 122167 0
Email 122167 0
sarah-catherine.rodan@sydney.edu.au
Contact person for scientific queries
Name 122168 0
Sarah-Catherine Rodan
Address 122168 0
University of Sydney, Level 6, Brain and Mind Centre, 94 Mallett Street, Camperdown, NSW, 2050
Country 122168 0
Australia
Phone 122168 0
+61 477222500
Fax 122168 0
Email 122168 0
sarah-catherine.rodan@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All original research data will remain strictly confidential. The de-identified research data will be disseminated in aggregate via conference presentations, peer-reviewed journal publications and media, as applicable, at the completion of the trial. Individual participant data will not be available. There are no commercial interests that are likely to delay or restrict the dissemination of these results. Eligible authors of publications will include investigators who provide substantial contribution to the conception and design of the study, or the acquisition, analysis, or interpretation of data for the work; and drafting the work or revising it critically for important intellectual content; and final approval of the version to be published.


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.