Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001303538p
Ethics application status
Submitted, not yet approved
Date submitted
23/09/2024
Date registered
28/10/2024
Date last updated
28/10/2024
Date data sharing statement initially provided
28/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The CanOPY Study: The efficacy of cannabidiol in addition to standard treatment in first episode psychosis in young people
Scientific title
The efficacy of cannabidiol adjunct to standard treatment in reducing positive psychotic symptoms in young people with first episode psychosis
Secondary ID [1] 312968 0
none
Universal Trial Number (UTN)
Trial acronym
CanOPY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
First episode psychosis 335139 0
Condition category
Condition code
Mental Health 331638 331638 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For 12 weeks, participants will receive daily oral doses of 1000 mg cannabidiol (CBD) or matched placebo, on a fixed schedule. Participants will continue to receive treatment as usual (TAU) with their current mental health provider during study treatment phase. All capsules will be identical containing 200mg of CBD or placebo, with participants instructed to take five capsules per day (two in the morning and three in the afternoon).

Treatment as usual will comprise antipsychotic medication and psychosocial treatment. Concomitant medication and psychosocial treatment type and frequency will be documented throughout the intervention period.

Treatment adherence will be assessed by regular capsule counts over the course of the study and objective quantification of cannabinoid levels in regular urine samples throughout treatment. Participants will also be asked to self-report their compliance at scheduled research assessments.
Intervention code [1] 329498 0
Treatment: Drugs
Comparator / control treatment
The comparator group will take 12 weeks of matched placebo alongside treatment as usual. The placebo capsules are formulated in hard gelatin. Each placebo capsule contains 600mg Softisan 378.
Control group
Placebo

Outcomes
Primary outcome [1] 339370 0
Positive psychotic symptoms
Timepoint [1] 339370 0
Baseline, week 4, week 8 and week 12 post-baseline
Secondary outcome [1] 439697 0
Response to the antipsychotic medication that was commenced immediately prior to the intervention period beginning (following failure of at least one adequately dosed trial of another antipsychotic medication).
Timepoint [1] 439697 0
Week 4, Week 8, and Week 12 post-baseline
Secondary outcome [2] 439698 0
Negative symptoms
Timepoint [2] 439698 0
Baseline, week 4, week 8 and week 12 post-baseline
Secondary outcome [3] 439699 0
Depression
Timepoint [3] 439699 0
Baseline, Week 4, Week 8 and Week 12 post-baseline
Secondary outcome [4] 439700 0
Overall clinical improvement
Timepoint [4] 439700 0
Baseline, week 4, week 8 and week 12 post-baseline
Secondary outcome [5] 439701 0
Social and occupational functioning. This will be assessed as a composite outcome.
Timepoint [5] 439701 0
Baseline, week 4, week 8 and week 12 post-baseline
Secondary outcome [6] 439702 0
Cognitive functioning
Timepoint [6] 439702 0
Baseline, week 4, week 8 and week 12 post-baseline
Secondary outcome [7] 439703 0
Quality of life
Timepoint [7] 439703 0
Baseline, week 4, week 8 and week 12 post-baseline
Secondary outcome [8] 439704 0
Safety and tolerability of CBD
Timepoint [8] 439704 0
Baseline, week 4, week 8 and week 12 post-baseline
Secondary outcome [9] 439705 0
Substance use
Timepoint [9] 439705 0
Baseline and Week 12 post-baseline
Secondary outcome [10] 439706 0
Cost-effectiveness
Timepoint [10] 439706 0
Baseline and Week 12 post-baseline

Eligibility
Key inclusion criteria
1. Aged 15-25 (inclusive) at entry;
2. Ability to give informed consent and adhere to study procedures (parental or guardian consent will be obtained for those aged <18 years);
3. Sufficient fluency in English for consent and assessment purposes);
4. First treated episode of a DSM-5 psychotic disorder;
5. Young people who meet criteria for first episode psychosis who have not responded to at least one adequate trial of antipsychotic medication and are within 2 weeks of having commenced a new antipsychotic medication
6. PANSS total score >70 corresponding to inadequate response to antipsychotic medication.
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior sensitivity or allergy to CBD or any cannabis-derived product;
2. If prescribed psychotropic medication (other than antipsychotic) the individual must have been on a stable dose for a minimum of 2 weeks;
3. Pregnancy, lactation, or if sexually active, no effective contraception;
4. Clinical blood test findings that might compromise participant safety or confound the trial results;
5. Acute or unstable systemic medical disorder;
6. Psychiatric condition due to a medical condition;
7. Severe disturbance, such that the person is unable to comply with either the requirements of informed consent or the treatment protocol.;
8. Diagnosis of a serious developmental disorder or a documented history of developmental delay or intellectual disability;
9. More than 3 months of continual prior antipsychotic medication use;
10. Psychotic symptoms only present during acute intoxication.

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)
After completion of the baseline assessment participants will be randomised to either of the two treatment groups. A randomisation list has been generated by an independent, unblinded statistician and passed onto the electronic database technician/designer. Therefore, allocation concealment is performed via central randomisation by a computer, which will then be inputted into the eCRF by the technician. Upon randomisation, an email will be sent directly to the pharmacy specifying which group the participant should be allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent statistician will conduct the computerised stratified randomisation. All personnel involved in teh study will be bvlinded to the randomisation sequence throughout the trial, execpt for the trial pharmacists. Participant ID numbers will not be reused.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA,VIC

Funding & Sponsors
Funding source category [1] 317400 0
Government body
Name [1] 317400 0
Department of Health and Aged Care - Medical Research Future Fund
Country [1] 317400 0
Australia
Primary sponsor type
University
Name
Orygen, The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 319761 0
None
Name [1] 319761 0
Address [1] 319761 0
Country [1] 319761 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316125 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 316125 0
Ethics committee country [1] 316125 0
Australia
Date submitted for ethics approval [1] 316125 0
22/04/2024
Approval date [1] 316125 0
Ethics approval number [1] 316125 0

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

Contacts
Principal investigator
Name 136874 0
Prof Paul Amminger
Address 136874 0
Orygen, 35 Poplar Rd Parkville Victoria 3052
Country 136874 0
Australia
Phone 136874 0
+61 401 846 430
Fax 136874 0
Email 136874 0
[email protected]
Contact person for public queries
Name 136875 0
Rebekah Street
Address 136875 0
Oryen, 35 Poplar Rd Parkville Victoria 3052
Country 136875 0
Australia
Phone 136875 0
+61 431 112 776
Fax 136875 0
Email 136875 0
[email protected]
Contact person for scientific queries
Name 136876 0
Paul Amminger
Address 136876 0
Orygen, 35 Poplar Rd Parkville Victoria 3052
Country 136876 0
Australia
Phone 136876 0
+61 401 846 430
Fax 136876 0
Email 136876 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.