ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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

2/07/2024

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]

none

Universal Trial Number (UTN)

N/A

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anxiety

Depression

Condition category

Condition code

Mental Health

Anxiety

Mental Health

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. Preparation session will consist of one two-hour session by team psychologist and psychology researcher that will occur in the week prior to administration of psilocybin 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 24hrs after capsule administration and outcome measures taken at 6- and 12-week follow-up.

Intervention code [1]

Treatment: Drugs

Intervention code [2]

Rehabilitation

Comparator / control treatment

None - open label uncontrolled

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Recruitment endpoint at 24hours after day of dosing; follow-up endpoint at 6 weeks and follow-up at 12-weeks

Primary outcome [2]

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]

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]

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]

Predose, 1h, 24h, 6-week, 12-week post-dose.

Secondary outcome [2]

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]

4 hours post-dosing

Secondary outcome [3]

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]

Predose, 1h, 24h, 6-week, 12-week post-dose

Secondary outcome [4]

Personality traits using NEO Personality Inventory-Revised (NEO-PI-R)

Timepoint [4]

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 18 years and over 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

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key 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 MAOIs, thyroxine or stimulants (amphetamine/methylphenidate). Use of antidepressants or other anxiolytics at stable doses > 4 weeks is acceptable.
6. Participants with severe acute or chronic medical illnesses.
7. Participants with a history of schizophrenia, psychosis, bipolar disorder, borderline personality disorder, and seizure disorders
6. Participants with current active suicidal ideation.
7. 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

1/02/2025

Actual

Date of last participant enrolment

Anticipated

1/07/2025

Actual

Date of last data collection

Anticipated

31/03/2026

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago

Address [1]

Country [1]

New Zealand

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Ashburn Clinic: James Humes Bequest Fund

Address [2]

Country [2]

New Zealand

Primary sponsor type

University

Name

University of Otago

Address

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Paul Glue - University of Otago

Address [1]

Country [1]

New Zealand

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Northern B Health and Disability Ethics Committee

Ethics committee address [1]

https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

18/06/2024

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

It has been shown that different psychological factors may influence a person’s response to treatment. For example, studies have shown that people with certain character traits, beliefs, thought processes etc may be more likely to respond to certain therapy or treatment more than others. Psilocybin has been shown to result in temporary changes in these mental processes that may create a change in the way a person receives and processes new information – such as psychological therapy. In this study, all participants will receive psilocybin within two to four weeks after completion of therapy, and then changes in mood and cognition will be followed-up.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Valerie Tan

Address

University of Otago, Department of Psychological Medicine, PO Box 56, Dunedin 9054, NZ

Country

New Zealand

Phone

+64 3 556 6256

Fax

[email protected]

Contact person for public queries

Name

Valerie Tan

Address

University of Otago, Department of Psychological Medicine, PO Box 56, Dunedin 9054, NZ

Country

New Zealand

Phone

+64 3 556 6256

Fax

[email protected]

Contact person for scientific queries

Name

Valerie Tan

Address

University of Otago, Department of Psychological Medicine, PO Box 56, Dunedin 9054, NZ

Country

New Zealand

Phone

+64 3 556 6256

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Current supporting documents:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23861	Informed consent form					386234-(Uploaded-07-06-2024-13-44-08)-Psilo PIS.docx

Updated to:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23861	Informed 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.

Trial Review

Documents added manually

Documents added automatically