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Trial registered on ANZCTR


Registration number
ACTRN12624001343594p
Ethics application status
Submitted, not yet approved
Date submitted
29/08/2024
Date registered
6/11/2024
Date last updated
6/11/2024
Date data sharing statement initially provided
6/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Psilocybin Medicine Open-Label Study (PMOS):
a determination of the safety and efficacy of psilocybin-assisted psychotherapy for patients with Treatment Resistant Major Depressive Disorder (TRD) within an Australian clinical context.
Scientific title
A determination of the safety and efficacy of psilocybin-assisted psychotherapy for patients with Treatment Resistant Major Depressive Disorder (TRD) within an Australian clinical context.
Secondary ID [1] 312848 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment Resistant Depression 334983 0
Condition category
Condition code
Mental Health 331501 331501 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study, patients diagnosed with treatment-resistant depression will undergo a comprehensive intervention combining psychotherapy with psilocybin treatment. Participants will receive two separate doses of 25 mg psilocybin capsules in two separate dosing sessions which will occur at visit 5 and 9, the first dosing session takes place after 3 psychotherapy preparation sessions and followed by a structured course of 3 psychotherapy integration sessions, followed by a second dosing session and a further 3 integration sessions. The entire treatment process will include 12 therapeutic sessions which may span approximately 16 to 18 weeks as appointments do not necessarily have to take pace weekly, they will involve both clinician and patient assessments to evaluate outcomes. After the patient is screened and onboarded, there are Monitoring attendance at scheduled preparation, dosing, and integration sessions will take place to ensure participants are following the therapy schedule, dosing session and the administration of medication will only occur under close, direct supervision. Post treatment process the patients will be followed up at 4 weeks and 6 months intervals.

Psilocybin-assisted therapy involves preparatory sessions to establish therapeutic goals and ensure readiness, followed by guided dosing sessions where the therapist supports the participant through their psychedelic experience, and integration sessions to help process and incorporate insights gained during the experience into everyday life. The therapy is designed to facilitate deep psychological exploration, emotional processing, and personal growth, with the therapist providing support and guidance throughout the process. Sessions will be 60 minutes in duration and generally weekly, depending on patient/clinician availability and schedule. The preferred mode of administration is face to face, however, patient requests for telehealth will be considered. However, the initial assessment and dosing sessions must always be face to face.

Strategies to assess adherence in psilocybin-assisted therapy include tracking attendance at scheduled sessions, monitoring completion of preparatory and integration sessions, and reviewing self-reported logs or diaries where participants document their experiences and adherence to the intervention. Additionally, therapists may conduct regular check-ins and follow-ups to ensure participants are engaging with the therapy as planned and address any issues that arise..
Intervention code [1] 329394 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339242 0
Depression symptoms
Timepoint [1] 339242 0
These will be administered at the beginning of the study to obtain baseline measurements, within one week of psilocybin administration, and again at the twelfth session which is the conclusion of their treastment.
Secondary outcome [1] 439535 0
Safety measurements
Timepoint [1] 439535 0
PMOS Patient Safety and AE Monitoring Questionnaire will be completed during the first visit, then every second visit through then every second visit through to the final integration session, then followed up at 4 weeks and 6 months post completion of treatment.
Secondary outcome [2] 439958 0
Depression Symptoms
Timepoint [2] 439958 0
Beck Depression Inventory (BDI) will be completed during the first visit, then every second visit through to the final integration session.
Secondary outcome [3] 439960 0
Participant rated change of symptoms
Timepoint [3] 439960 0
The Patient Global Impression of Change (PGIC) be completed during the first visit, then every second visit through to second visit through to the final integration session
Secondary outcome [4] 439961 0
World Health Organisation Quality of Life Questionnaire (WHO-QoL-Bref)
Timepoint [4] 439961 0
World Health Organisation Quality of Life Questionnaire (WHO-QoL-Bref) will be completed during the first visit, then every second visit through through to the final integration session

Eligibility
Key inclusion criteria
The following inclusion criteria will be used:
1. Adults aged 18 years or older;
2. Understanding of English (with interpreter if needed) who have provided, or have capacity to provide informed consent;
3. Are capable of conforming to study related procedures;
4. Participants with a medical history of Major Depressive Disorder (SCID-5) and are currently experiencing a major depressive episode with low risk of suicidality;
5. Participants with a baseline GRID-HAMD score greater than or equal to 20, indicating moderate-severe depression;
6. Participants must have failed to respond to achieve a clinical response to two or more adequate courses of antidepressants, preferably across at least two different classes of medication for a minimum of three weeks at the minimum effective dose. The definition of ‘failed to respond’ is an inadequate response to an adequate duration and dose, or failure to reach an adequate dose and duration due to lack of tolerance;
7. Participants who are attending psychotherapy that has been stable for at least two months prior to screening and is expected to remain stable for the duration of the study;
8. Participants must be clinically stable as determined by screening for medical problems via a personal interview, a health questionnaire, a physical examination, an electrocardiogram (ECG), and clinical laboratory screening such as blood tests and urinalysis; (ECG and bloods will be collected by a private provider, not by GoodMind Therapeutics)
9. Patient should be willing to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of drug session days;
10. Participants should refrain from using any psychoactive drugs or illicit substances, including alcoholic beverages and nicotine, within 48 hours of each psilocybin administration (with the exception of caffeine);
11. Participants should be compliant with not taking any medicines that are only ‘used when needed’ or PRN on the mornings of drug sessions or the night prior;
12. Participant should be willing to refrain from taking any non-prescription medication, nutritional supplement, or herbal supplement, one week before each drug session, except when approved by the study investigators (exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and doses of common vitamins and minerals);
13. Have minimal hallucinogen use in the past five years and a total hallucinogen use less than 10 times.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following exclusion criteria will be used:
1. Evidence of significant suicide risk, including a history of medically significant suicide attempts;
2. Depression secondary to another medical condition;
3. Judged incompatible with establishment of rapport with the therapy team and/or safe exposure to psilocybin e.g., suspected borderline personality disorder;
4. Any patient with moderate–severe hepatic and/or renal dysfunction, major CNS disorders, and diagnosed with epilepsy, or has a history of seizure activity ;
5. Patients with cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality, prolonged QTc interval, artificial heart valve, or transient ischaemic attack in the past year;
6. Has a history of diabetic neuropathy or has presence of significant endocrine disorder;
7. If taking oral hypoglycaemic agent, then no history of hypoglycaemia;
8. Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or lactating mothers;
9. Women of child-bearing age who are not on birth control and not practising safe sex activities;
10. For individuals who have intermittent or PRN use of medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose;
11. Participants taking medications including: Rifamycin, rifampin, rifabutin, rifapentine, carbamazepine, phenytoin, phenobarbital, nevirapine, efavirenz, paclitaxol, St John's Wort, all HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, or troleandomycin;
12. Patients with a history of DSM-5 eligibility criteria for moderate or severe alcohol misuse, any illicit drug or alcohol dependence syndrome, schizophrenia spectrum or other psychotic disorders (including substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder;
13. Have a history of, or a first degree relative with a history of psychosis or mania, schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or bipolar affective disorder (type I or type II); any personality disorder or dementia.
14. Had a previous psychotic episode or any other psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin.
15. Known allergic or other adverse reaction to psilocybin or any excipients contained within the capsule, including lactose.

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
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data will be analysed using SPSS (v25.0, IBM Analytics, Armonk, NY). Descriptive statistics will be produced with summary data regarding participant demographics, treatment, and patient-reported assessments. Continuous variables with normal distribution will be presented as means with standard deviation (SD); non-normal distribution will be presented as medians with an interquartile range (IQR). Categorical variables will be presented as counts and percent of the total.
The study will use t-test for the analysis of the continuous variables with normal distribution, and non-parametric Wilcoxon test used whenever parametric assumptions are not satisfied. Longitudinal outcome data over time (i.e., changes from baseline) will be analysed using repeated measures analysis (e.g., ANOVAs or ANCOVAs to correct for any confounding variables).
Multivariate Logistic regression will be used to analyse factors associated with treatment outcomes and Bonferroni-corrected to adjust for multiple testing.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/11/2024
Actual
Date of last participant enrolment
Anticipated
20/11/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317288 0
Commercial sector/Industry
Name [1] 317288 0
GM Therapeutics Pty Ltd.
Country [1] 317288 0
Australia
Funding source category [2] 317290 0
Other
Name [2] 317290 0
This study will be funded by GM Therapeutics Pty Ltd. The funding will cover the cost of research staff, including training, development of data management systems and protocol development by the staff at GM Therapeutics.
Country [2] 317290 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
GoodMind Therapeutics
Address
Country
Australia
Secondary sponsor category [1] 319570 0
None
Name [1] 319570 0
None
Address [1] 319570 0
Country [1] 319570 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316025 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 316025 0
Ethics committee country [1] 316025 0
Australia
Date submitted for ethics approval [1] 316025 0
20/06/2024
Approval date [1] 316025 0
Ethics approval number [1] 316025 0

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

Contacts
Principal investigator
Name 136546 0
Dr David Graham
Address 136546 0
GoodMind Therapeutics, 5/2 Barrack Street, Sydney, NSW, 2000
Country 136546 0
Australia
Phone 136546 0
+61 401265713
Fax 136546 0
Email 136546 0
david.graham@goodmindtherapeutics.com.au
Contact person for public queries
Name 136547 0
John Paul Pitchford
Address 136547 0
GoodMind Therapeutics, 5/2 Barrack Street, Sydney, NSW, 2000
Country 136547 0
Australia
Phone 136547 0
+61261900408
Fax 136547 0
Email 136547 0
john.pitchford@goodmindtherapeutics.com.au
Contact person for scientific queries
Name 136548 0
John Barlow
Address 136548 0
GoodMind Therapeutics, 5/2 Barrack Street, Sydney, NSW, 2000
Country 136548 0
Australia
Phone 136548 0
+61 411193792
Fax 136548 0
Email 136548 0
info@goodmindtherapeutics.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No - IPD will not be publicly available. Due to confidentiality and privacy considerations, individual participant data (IPD) will be de-identified and published in aggregate form only.


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.