CanARY
ACTRN12621000349842
Charities/Societies/Foundations, Wellcome Trust (UK)
Prof Paul Amminger
The proposed study aims to answer an important clinical question: can subthreshold psychotic manifestations be effectively treated with cannabidiol (CBD), a non-psychoactive compound of the plant Cannabis sativa? The question has taken on increased clinical importance in the wake of recent evidence questioning the need and efficacy of specific interventions in the UHR group. This study will test CBD for the first time in the UHR phase of psychotic disorder.
1. Aged 12-25 years (inclusive) at entry; 2. Sufficient fluency in English (for assessment purposes); 3. Ability to provide informed consent (parental/guardian consent will be obtained for participants aged <18 years); 4. Meeting one or more UHR for psychosis groups as defined in Table 1 of the study protocol; and 5. Attenuated psychotic symptoms present in the past month at UHR level as defined in Table 1 of the study protool.
1. Ultra-High Risk symptoms only present during acute intoxication 2. If prescribed psychotropic medication (e.g. antidepressant medication) the individual must have been on a stable dose for a minimum of 6 weeks prior to randomisation). Antipsychotic medication is not an exclusion criterion. In the case of current antipsychotic use, medication will be tapered and ceased at entry to the study. 3. Pregnancy, lactation, or if sexually active, no effective contraception (applies to both male and fe .... Read more
No
Sample Size 405
Min. age 12 Years
Max. age 25 Years
Sex Both males and females
Condition category Ultra-High Risk of Psychosis
Condition code Mental Health
Intervention code Prevention , Treatment: Drugs
CanARY is a Randomised Controlled Trial examining the feasibility of Cannabidiol (CBD) as a treatment for young people aged 12 - 25 years who have been identified as Ultra-High Risk of Psychosis. CanARY is a three-arm RCT with a placebo and 2 discrete drug doses randomised to the ratio 1:1:1. The study is double-blind. Participants will be asked to take the study intervention for 12 weeks. CBD (per oral) – doses of 600mg or 1000mg per day (fixed schedule) for 12 weeks - All participants will tak .... Read more
Control group Placebo
There will be one placebo group. The placebo group will orally take 2 x tablets in the morning and 3 x tablets in the evening. The placebo tablets are formulated in hard gelatin capsules, each placebo capsule contains 600mg Softisan 378.
Outcome: Severity of positive psychotic symptoms on the Comprehensive Assessment of At-Risk Mental States (CAARMS) Timepoint: Week 12 post intervention commencement.
yes
Only meta-data / information about the study will be displayed on the catalogue.
Data are currently embargoed. They will be available after the main results have been published for an indefinite time.
Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data management policy.
To any type of analyses. Assessed on a case-by-case basis.
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