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Trial registered on ANZCTR


Registration number
ACTRN12624000816550p
Ethics application status
Submitted, not yet approved
Date submitted
7/06/2024
Date registered
2/07/2024
Date last updated
3/11/2024
Date data sharing statement initially provided
2/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility study testing the protocol of single dose of psilocybin given to people who have had little improvements with brief psychological intervention
Scientific title
Feasibility Study of the Effect of Psilocybin in Response to Brief Psychological Input with Psychological Flexibility as a Mediating Factor on adults with Mild to Moderate Depression or Anxiety.
Secondary ID [1] 310114 0
none
Universal Trial Number (UTN)
N/A
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 334046 0
Depression 334047 0
Condition category
Condition code
Mental Health 330717 330717 0 0
Anxiety
Mental Health 330718 330718 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. This study is an open label fixed sequence study design of participants with mood disturbances (mild – moderate depression/anxiety symptoms) who have had limited improvements from brief psychological intervention. Participants will be recruited after brief intervention with psychological services such as Student Health, Community Mental Health Teams, or private clinics.
2. Screening session will consist of one two-hour session by team psychologist and psychology researcher that will occur within a month after end of brief psychological intervention which includes psychoeducation about the dosing and baseline measures.
3. Single dose of psilocybin administration (25mg) orally in the morning at the start of 8-hour long monitoring while reviewing content from participants' previous brief psychological input that they have learnt from their previous individual therapy sessions. The specific content is not controlled for aside from ensuring that they contain elements of Acceptance Commitment Therapy components - the range of content will be part of the descriptive analysis.
4. Acute measures will be taken approximately 4hrs after capsule administration, subacute measures taken 24hrs after, and outcome measures taken at 6- and 12-week follow-up.
Intervention code [1] 328776 0
Treatment: Drugs
Intervention code [2] 328838 0
Rehabilitation
Comparator / control treatment
None - open label uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338478 0
Recruitment and retention rates at dosing and follow-up – the ability to recruit and retain the targeted number of participants within the specified timeframe.
Timepoint [1] 338478 0
Recruitment endpoint at 24hours after day of dosing; follow-up endpoint at 6 weeks and follow-up at 12-weeks
Primary outcome [2] 338479 0
Adherence to protocol – examining the participants and research team in adhering to study protocol such as with preparation, dosing schedule, and follow-ups.
Timepoint [2] 338479 0
Single preparation session at baseline, single session of acute measurements 24-hour after psilocybin administration, single follow-up measure at 6-weeks and single follow-up measure at 12-weeks.
Secondary outcome [1] 436078 0
Depression and/or anxiety ratings as a composite outcome using Depression Anxiety Stress Scale-21 (DASS-21), Beck Anxiety Inventory BAI, Beck Depression Inventory BDI-2
Timepoint [1] 436078 0
Predose, 1h, 24h, 6-week, 12-week post-dose.
Secondary outcome [2] 436727 0
Measures of acute psychedelic experiences as a composite outcome: Insight, mystical experiences, and challenging experiences using Mystical Experiences Questionnaire (MEQ); Challenging Experience Questionnaire (CEQ); Psychological Insight Questionnaire (PIQ)
Timepoint [2] 436727 0
4 hours post-dosing
Secondary outcome [3] 436728 0
Trait measures as a composite outcome: Psychological flexibility, experiential avoidance using Acceptance and Action Questionnaire – 2 (AAQ-2); Brief Experiential Avoidance Questionnaire (BEAQ)
Timepoint [3] 436728 0
Predose, 1h, 24h, 6-week, 12-week post-dose
Secondary outcome [4] 436729 0
Personality traits using NEO Personality Inventory-Revised (NEO-PI-R)
Timepoint [4] 436729 0
predose, 1h, 24h, 6-week, 12-week post-dose

Eligibility
Key inclusion criteria
1. Capable of understanding and signing an informed consent form.
2. Aged 25 - 60 years on the day of consent.
3. Psychiatric history: Clinical interviews and assessments by referral agent – psychologists at student health/community mental health teams/private clinics
4. Participants with anxiety: Baseline scores of moderate to severe anxiety according to DASS-21 criteria and clinical assessment from referral agent (psychologist)
5. Participants with depression: Baseline scores of moderate to severe depression according to DASS-21 criteria and clinical assessment from referral agent (psychologist)
Minimum age
25 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
To be included in the study, participants must meet none of the following exclusion criteria:
1. Female Participants who are or intend to become pregnant, or are lactating.
2. Participants who, in the opinion of the investigator, do not understand the information and procedures of the study, or would not be compliant with them (in particular the study restrictions and risks involved).
3. Any participant for whom the investigator believes, for any reason, that participation would not be an acceptable risk.
4. Participants with cardiovascular conditions
5. Current use of antidepressants, anxiolytics, MAOIs, thyroxine or stimulants (amphetamine/methylphenidate).
6. Participants with severe, acute or chronic medical illnesses.
7. Participants with a history of schizophrenia, psychosis, bipolar disorder, borderline personality disorder, or seizure disorders.
8. Participants with a family history of schizophrenia, psychosis, or bipolar disorder.
9. Participants with current active suicidal ideation.
10. Substance abuse disorder, current or within the last 6 months.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed models will be used to explore changes from baseline to 6 weeks (the primary endpoint), baseline to 12 weeks, and between 6 and 12 weeks.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
1/11/2025
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 26366 0
New Zealand
State/province [1] 26366 0
Otago

Funding & Sponsors
Funding source category [1] 314274 0
University
Name [1] 314274 0
University of Otago
Country [1] 314274 0
New Zealand
Funding source category [2] 316750 0
Charities/Societies/Foundations
Name [2] 316750 0
Ashburn Clinic: James Humes Bequest Fund
Country [2] 316750 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 318896 0
None
Name [1] 318896 0
Address [1] 318896 0
Country [1] 318896 0
Other collaborator category [1] 283080 0
Individual
Name [1] 283080 0
Paul Glue - University of Otago
Address [1] 283080 0
Country [1] 283080 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313394 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 313394 0
Ethics committee country [1] 313394 0
New Zealand
Date submitted for ethics approval [1] 313394 0
18/10/2024
Approval date [1] 313394 0
Ethics approval number [1] 313394 0

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

Contacts
Principal investigator
Name 127994 0
Dr Valerie Tan
Address 127994 0
University of Otago, Department of Psychological Medicine, PO Box 56, Dunedin 9054, NZ
Country 127994 0
New Zealand
Phone 127994 0
+64 3 556 6256
Fax 127994 0
Email 127994 0
valerie.tan@otago.ac.nz
Contact person for public queries
Name 127995 0
Valerie Tan
Address 127995 0
University of Otago, Department of Psychological Medicine, PO Box 56, Dunedin 9054, NZ
Country 127995 0
New Zealand
Phone 127995 0
+64 3 556 6256
Fax 127995 0
Email 127995 0
valerie.tan@otago.ac.nz
Contact person for scientific queries
Name 127996 0
Valerie Tan
Address 127996 0
University of Otago, Department of Psychological Medicine, PO Box 56, Dunedin 9054, NZ
Country 127996 0
New Zealand
Phone 127996 0
+64 3 556 6256
Fax 127996 0
Email 127996 0
valerie.tan@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
These feasbility data will be used to develop a subsequent blinded placebo controlled study. These latter data may be made available publicly.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23861Informed consent form    386234-(Uploaded-18-10-2024-12-55-19)-Psilo PIS v2 Oct 2024.pdf



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.