Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000040561
Ethics application status
Approved
Date submitted
7/12/2023
Date registered
17/01/2024
Date last updated
17/01/2024
Date data sharing statement initially provided
17/01/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Psychedelic Therapy for Treatment Resistant Depression (TRD)
Scientific title
Effectiveness of Psychedelic Therapy for Treatment Resistant Depression (TRD)
Secondary ID [1] 311141 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment Resistant Depression (TRD) 332307 0
Condition category
Condition code
Mental Health 329017 329017 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Psilocybin medicines are given orally in a capsule form once in the morning on the medicine days only. The medicine dosing is by the treating psychiatrist, and he will ensure the patient has swallowed the medicine at dosing. No other strategies are available or indicated. The medicines used are psilocybin for Treatment Resistant Depression.
Medicine days occur 2-3 times (depending on response to treatment) interspersed with psychotherapy:
ie 3 Preparatory sessions/1 Medicine Day/3 Integration Sessions 1 week apart/ 1 Medicine Day/ 3 Integration Sessions 1 week apart/ Then an optional 3rd Medicine Day and 3 Integration Sessions 1 week apart, if there's an inadequate response to treatment
Psilocybin (25mg + optional 10mg) given once in morning on 2-3 medicine days through the treatment interspersed with psychotherapy. The usual dose will be 25mg. 10mg top up will only be if there is an inadequate clinical response to the 25mg dose.
Psychotherapy (all sessions are 1 hour)
• Three preparation sessions held approximately a week apart.
Dr Ranil Gunewardene will conduct the first preparation session 1:1 in rooms or via Zoom for 60 minutes. During this session, further in depth assessment will take place and medical review.

The second and third preparation session will be with a HREC approved Psychologist/ psychotherapist 1:1 either in rooms or via Zoom for 1 hour each.

• One Dosing session ( approximately 6-7 hours face to face) where supportive, client centered psychotherapy is provided during the dosing experience at Northern Beaches Hospital Clinic Rooms. Psychiatrist Dr Ranil Gunewardene will conduct the administration of medicine, regular monitoring and medical supervision of the client. Dr Ranil Gunewardene will provide direct client time face to face as clinically required. The designated treating HREC approved Psychologist/ Psychotherapist will work face to face with the client throughout their dosing day providing client centered psychotherapy.

• Three Integration sessions conducted 1:1 by HREC approved the psychologist/ psychotherapist with the first one held the day after the dosing session and then held approximately a week apart.

• Who:
HREC approved Psychologists/Psychotherapists conducting the preparation sessions, dosing and integration therapy sessions are all fully registered and have additional training in psychedelic assisted therapy.

Mode of Administration:
Preparation and Integration sessions will be 1:1 with a psychologist/ psychotherapist or psychiatrist and will be offered either face to face or via Zoom for 60 minutes.
Monitoring:
• The treatment dyad consisting of Dr Ranil Gunewardene and one of the HREC approved PAT trained psychologists/psychotherapists will be consistent across the course of the treatment and will ensure follow up any non attendance at appointments with telephone contact from the clinic to support adherence to the full therapy program.
• A spreadsheet that records client dates of sessions and disengagement from the therapy program prior to completion will be recorded along with action taken to re-engage the client.
• Adverse Events will be recorded and reported to HREC and TGA
• Pre and post psychometric measures will be administered.

Psychedelic Assisted Psychotherapy for Psilocybin is taught during Psychedelic Assisted Therapy training programs that have been completed by all of the psychologists/psychotherapists and the psychiatrist delivering the service.
In Summary the therapy approach for all sessions is simply supportive psychotherapy based. There is psychoeducation delivered and set setting and relationship building is undertaken. The therapist is encouraged to stay out of the way of the patient’s medicine guided realisations and perspective shifts. To be guided by the patient’s experiences not the therapist’s agenda. To encourage the rediscovering of the wiser self and to promote patient agency. The therapist is there to support the patient rediscovering and connecting to their “inner healing intelligence”. There are principles of emotional support, encouragement, validation of experiences and perspectives, exploration of feeling states, in a non directive and non judgmental therapist stance.

Intervention code [1] 327585 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336813 0
Change in clinician rated depression severity
Timepoint [1] 336813 0
baseline and 2 weeks post treatment
Secondary outcome [1] 429741 0
Change in self rated mental health
Timepoint [1] 429741 0
baseline and 2 weeks post treatment
Secondary outcome [2] 429742 0
Change in suicidal ideation
Timepoint [2] 429742 0
baseline and 2 weeks post treatment
Secondary outcome [3] 429743 0
Change in disability
Timepoint [3] 429743 0
baseline and 2 weeks post treatment
Secondary outcome [4] 429744 0
Change in connection
Timepoint [4] 429744 0
baseline and 2 weeks post treatment
Secondary outcome [5] 430195 0
Change in quality of relationships from baseline
Timepoint [5] 430195 0
baseline and 2 weeks post treatment
Secondary outcome [6] 430196 0
Change in mystical experiences
Timepoint [6] 430196 0
baseline and 2 weeks post treatment
Secondary outcome [7] 430197 0
Change in alcohol use from baseline
Timepoint [7] 430197 0
baseline and 2 weeks post treatment
Secondary outcome [8] 430198 0
Change in drug use from baseline
Timepoint [8] 430198 0
baseline and 2 weeks post treatment
Secondary outcome [9] 430776 0
Change in eating attitudes from baseline
Timepoint [9] 430776 0
baseline and 2 weeks post treatment
Secondary outcome [10] 430777 0
Change in disordered eating from baseline [Substudy for patients with symptoms of an eating disorder]
Timepoint [10] 430777 0
baseline and 2 weeks post treatment
Secondary outcome [11] 430778 0
Change in eating disorder symptomology from baseline [Substudy for patients with symptoms of an eating disorder]
Timepoint [11] 430778 0
baseline and 2 weeks post treatment

Eligibility
Key inclusion criteria
Must suffer from TRD
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Is not able to give adequate informed consent, or is under 18 or over 65 years old.
(2) Has uncontrolled hypertension or unstable diabetes.
(3) Has a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds [ms] corrected by Bazett's formula)1
(4) Has a history of additional risk factors for Torsade de pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome).
(5) Has evidence or history of significant medical disorders e.g. epilepsy, stroke, unstable cardio vascular disease
(6) Has symptomatic liver disease.
(7) Has a history of hyponatremia or hyperthermia.
(8) Weighs less than 48 kg.
(9) Is pregnant or nursing or is of childbearing age and is not practicing an effective means of birth control.
10) Is currently abusing illegal drugs

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/12/2023
Date of last participant enrolment
Anticipated
18/12/2028
Actual
Date of last data collection
Anticipated
5/01/2029
Actual
Sample size
Target
30
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315396 0
Self funded/Unfunded
Name [1] 315396 0
Patients are self funded or may be funded by an organisation eg Insurance Company or DVA
Country [1] 315396 0
Primary sponsor type
Individual
Name
Dr and A/ Professor Ranil Gunewardene
Address
Mindlife Clinic Suite 18 Level 7 Northern Beaches Hospital, 105 Frenchs Forest Road Frenchs Forest NSW 2086
Country
Australia
Secondary sponsor category [1] 317459 0
None
Name [1] 317459 0
Address [1] 317459 0
Country [1] 317459 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314314 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 314314 0
Ethics committee country [1] 314314 0
Australia
Date submitted for ethics approval [1] 314314 0
16/10/2023
Approval date [1] 314314 0
08/11/2023
Ethics approval number [1] 314314 0
HREC/2023/QTHS/103245

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

Contacts
Principal investigator
Name 131150 0
A/Prof Dr Ranil Gunewardene
Address 131150 0
Mindlife Clinic, Northern Beaches Hospital Suite 18 level 7, 105 Frenchs Forest Road West Frenchs Forest NSW 2086
Country 131150 0
Australia
Phone 131150 0
+61 0466534211
Fax 131150 0
Email 131150 0
ranil0001@yahoo.com.au
Contact person for public queries
Name 131151 0
Kitrina Heathcoate
Address 131151 0
Mindlife Clinic, Northern Beaches Hospital Suite 18 level 7, 105 Frenchs Forest Road West Frenchs Forest NSW 2086
Country 131151 0
Australia
Phone 131151 0
+61 0424292306
Fax 131151 0
Email 131151 0
reception@mindlifeclinic.com
Contact person for scientific queries
Name 131152 0
Dr Ranil Gunewardene
Address 131152 0
Mindlife Clinic, Northern Beaches Hospital Suite 18 level 7, 105 Frenchs Forest Road West Frenchs Forest NSW 2086
Country 131152 0
Australia
Phone 131152 0
+61 0466534211
Fax 131152 0
Email 131152 0
ranil0001@yahoo.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
Data is grouped into assessment scale scores for all patients


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.