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Trial registered on ANZCTR


Registration number
ACTRN12623000618651
Ethics application status
Approved
Date submitted
9/05/2023
Date registered
6/06/2023
Date last updated
29/08/2024
Date data sharing statement initially provided
6/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploratory trial to assess the efficacy and safety of Psilocybin-Assisted Psychotherapy (PAP) involving family-members compared to standard PAP, in adults with treatment-resistant major depressive disorder. (TRMDD).
Scientific title
Exploratory trial to assess the efficacy and safety of Psilocybin-Assisted Psychotherapy (PAP) involving family-members compared to standard PAP, in adults with treatment-resistant major depressive disorder. (TRMDD).
Secondary ID [1] 309625 0
CT-2022-CTN-03002-1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment-resistant major depressive disorder (TRMDD). 329944 0
Condition category
Condition code
Mental Health 326851 326851 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will receive two separate doses of 25 mg of psilocybin 3 weeks apart from each other. in the form of a capsule Which they will take orally with water in the presents of the approved treating team members. This is in line with the schedule 9 licence agreement. They will be asked to consent verbally before receiving each dose. To minimise the risk of PAP-related nausea and vomiting, they should fast eight hours prior to receiving the dose and not drink anything 30 minutes prior to receiving psilocybin. When administered the psilocybin, each participant will be accompanied and monitored at all times by the treating therapists for a minimum of 6 hours (until the acute psychological effects of the drug wear off) and a medically qualified person that will be available at all times.
Group 1: The treating Clinical Psychologists (Two will be always present) will remain in the room with the participant. The supporting family member will only be present for the Preparation period of the study and will not be present during the treatment sessions. Active Psychotherapy will take place following medication administration. During the preparation session, the family member will get to meet the therapists that will be with them during the entire study. Throughout this session, the therapists will explain the study team’s expectations on how they are to conduct yourself during and after each PAP session. This baseline visit/visit 3 may take approximately 2.5 hours. They are encouraged and must feel free to ask any questions you feel like asking.

Group 2: The treating Clinical Psychologists (Two will be always present) will remain in the room with the participant. Active Psychotherapy will take place following medication administration.
Intervention code [1] 326052 0
Treatment: Drugs
Comparator / control treatment
This is a randomised controlled research project, Group 1: receiving PAP with therapists in the presence of a family member.
Group 2: receiving PAP only with therapists.
Group 2 will be the comparator treatment.
Control group
Active

Outcomes
Primary outcome [1] 334703 0
The primary outcome will be compared between groups using Hamilton Depression Rating Scale (HDRS).
Timepoint [1] 334703 0
12 months following last psychotherapy session.
Secondary outcome [1] 421817 0

To evaluate the efficacy of PAP with or without involving family-members for the treatment of Treatment Resistant Major Depressive Disorder using the Montgomery–Åsberg Depression Rating Scale (MADRS)
Timepoint [1] 421817 0
12 months following last psychotherapy session.

Eligibility
Key inclusion criteria
Participant must be over 18 years of age inclusive, up to 65 years old at
the time of signing the informed consent.
Participant is able to read, understand and agree with the procedures of
the study.
Participants must be diagnosed with major depressive disorder and have
moderate to severe depression (17+ on the 17-item Hamilton Depression
Rating scale [HAM-D17]).
Participants have failed to respond to two adequate courses of
antidepressant treatment of different pharmacological classes lasting at least
6 weeks within the current depressive episode and have not been subject to
Electroconvulsive therapy (ECT) within 6 months prior to the study.
Participants can confirm the involvement and willingness of a family
member during the PAP sessions and duration of the study
Male participants are eligible to participate if they agree to the following
during the study intervention period and for at least 3 months after the
last administration of study intervention:
- Refrain from donating sperm PLUS, either:
- Be abstinent from heterosexual intercourse as their preferred and
usual lifestyle (abstinent on a long term and persistent basis) and
agree to remain abstinent OR;
- Must agree to use contraception/barrier method (condom); the
participant should also be advised of the benefit for a female partner
to use a highly effective method of contraception.
b. Female participants:
A female participant is eligible to participate if she is not pregnant or
breastfeeding, and one of the following conditions applies:

- Is a woman of nonchildbearing potential (WONCBP) such as a woman
in postmenopausal state (has experienced no menses for 12
consecutive months without an alternative medical cause); OR
- Has a documented permanent sterilization method such as:
o Documented hysterectomy
o Documented bilateral salpingectomy
o Documented bilateral oophorectomy, OR
Is a woman on childbearing potential (WOCBP) and agrees to use a
contraceptive method that is highly effective (with a failure rate of
<1% per year), with low user dependency.
A WOCBP must have a negative highly sensitive pregnancy test (urine) during
screening and prior to each psylocibin administration.
Consent for study team to contact participant’s HCP team to notify them
of trial participation and for the arrangement of follow-up care in the event
of discontinuation from the trial (including discontinuation due to withdrawal
of consent from trial participation
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants unable to provide written informed consent.
Participants with history of current or previously diagnosed psychotic
disorder, or bipolar disorder.
Immediate family member with a diagnosed psychotic disorder.
Participants that are pregnant or breastfeeding. Positive pregnancy test
at screening or prior to any psilocybin administration or refusal to have an
on-site B-HCG pregnancy test prior to any psilocybin administration.
Participants who may have sexual contact, without contraceptive
measures, with a person who may become pregnant during or within 90 days
(or 3 months) of cessation of the psilocybin IMP.
Participants with history of serious suicide attempts or with a current
Columbia-Suicide Severity Rating Scale (C-SSRS) positive (YES) for questions
4,5 or 6, or deliberate self-harm within the last year.
Participants with any of Cluster B personality disorder such as:
• Borderline personality disorder
• Histrionic personality disorder
• Antisocial personality disorder
• Narcissistic personality disorder
Participants with eating disorders such as:
• Anorexia Nervosa
• Bulimia Nervosa
• Binge Eating Disorder
• Other Specified Feeding and Eating Disorder
• Pica
• Rumination Disorder
• Avoidant/Restrictive Food Intake Disorder
• Unspecified Feeding or Eating Disorder
• Other:
o Muscle Dysmorphia
o Orthorexia Nervosa
Participants who are receiving any Selective Serotonin recapture Inhibitor
(SSRI) during the last 4 weeks. A washout period of 4 weeks (5 weeks for
fluoxetine) prior to the enrolment is permitted. Patients who have received an
Inhibitor of Mono-amino-oxidase (MAOIs) or patients receiving any other agent
that may precipitate a serotonin syndrome (such as, but not limited to: LTryptophan, Selective Serotonin Reuptake Inhibitors, Tricyclic antidepressants,
Tramadol, Buspirone, Amphetamines and anorectics, Atypical antidepressants,
St John’s wort, or Lithium) in the previous 4 weeks before the study enrollment.
Participants with known history of serotonin syndrome, neuroleptic
malignant syndrome or malignant hyperthermia.
Moderate to severe systolic or diastolic hypertension, or uncontrolled
mild hypertension, a previous hypertensive crisis or a known or suspected
aneurysm or history of intracerebral haemorrhage.
Participants with evidence of mild to severe moderate hepatic
impairment (Child Pughclass A-C)
Participants with evidence of mild to severe renal impairment
(GFR <70mL/min)
Hypersensitivity to any of the study interventions, including any
constituents thereof, or drug or other allergy that, in the opinion of the
Investigator, contraindicates participation in the study.
Clinically significant abnormal ECG at screening/baseline or during the
dosing period that may, in the judgement of the investigator, affect the
conduct of the study.
Participants with known history of prolonged QT interval conditions or
taking other medications that can prolong QT interval (such as, but not
limited to: amiodarone, astemizole, chlorpromazine, cisapride, erythromycin,
papaverine, procainamide, quinidine, sotalol, terfenadine, vandetanib).
Substance use disorder (excluding nicotine or caffeine) current or in the
last year. Alcohol Use Disorder is as defined per DSM-5. Participants who do
not anticipate being able to refrain from smoking or vaping for 12 hours are
excluded.
Participants not suitable for participation, whatever the reason, as
judged by the Investigator, including medical or clinical conditions that might
affect their safety or ability to complete the protocol or that may confound
the efficacy or safety results of the trial.
Participants who are employees of the clinical study site or other
individuals directly involved in the conduct of the study, or immediate family
members of such individuals.
Individuals accommodated in an institution because of regulatory or
legal order; prisoners or participants who are legally institutionalised.
Any specific situation during study that may raise ethics considerations

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 0
Type of endpoint/s
Efficacy
Statistical methods / analysis
A statistical analysis of the primary endpoint will be performed at week 6 vs baseline in both
treatment groups. For HAM-D to achieve 80% power to detect a difference between arms of 5.4
points and in the secondary endpoint for MADRS, to achieve 80% power to detect a difference of
7.2 with a 5% drop-out, approximately 60 participants will be included in this study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/01/2024
Actual
17/01/2024
Date of last participant enrolment
Anticipated
6/01/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
60
Accrual to date
24
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 24691 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 40314 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 313806 0
Commercial sector/Industry
Name [1] 313806 0
Reset Mind Science
Country [1] 313806 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Reset Mind Science
Address
PO Box 690
West Perth, WA 6872
Country
Australia
Secondary sponsor category [1] 315638 0
None
Name [1] 315638 0
Address [1] 315638 0
Country [1] 315638 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312970 0
South Metropolitain Health Service Human Ethics Committe
Ethics committee address [1] 312970 0
Ethics committee country [1] 312970 0
Australia
Date submitted for ethics approval [1] 312970 0
30/08/2022
Approval date [1] 312970 0
08/11/2022
Ethics approval number [1] 312970 0

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

Contacts
Principal investigator
Name 126530 0
Prof Sean Hood
Address 126530 0
University of Western Australia
35 Stirling Highway
Perth WA 6009 Australia
Country 126530 0
Australia
Phone 126530 0
+61 08 6457 2140
Fax 126530 0
Email 126530 0
sean.hood@uwa.edu.au
Contact person for public queries
Name 126531 0
Sean Hood
Address 126531 0
University of Western Australia
35 Stirling Highway
Perth Western Australia
6009 Australia
Country 126531 0
Australia
Phone 126531 0
+61 08 6457 2140
Fax 126531 0
Email 126531 0
sean.hood@uwa.edu.au
Contact person for scientific queries
Name 126532 0
Sean Hood
Address 126532 0
University of Western Australia
35 Stirling Highway
Perth Western Australia
6009 Australia
Country 126532 0
Australia
Phone 126532 0
+611300703999
Fax 126532 0
Email 126532 0
sean.hood@uwa.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
Reasons of confidentiality


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.