This dataset captures data from a randomized controlled trial evaluating the feasibility of cannabidiol (CBD) as a treatment for young people aged 12-25 at Ultra-High Risk (UHR) of psychosis. It includes information on participants’ adherence to the intervention, which involved daily doses of 600mg or 1000mg of CBD or a placebo over 12 weeks. The dataset records clinical assessments, adverse events, medication adherence, and biomarker data (e.g., blood, urine, hair samples) collected at multiple time points, including baseline, weeks 4, 8, 12, and follow-up visits up to 104 weeks. The dataset from the CanARY Study includes key variables assessing the impact of cannabidiol (CBD) on positive psychotic symptoms in youth at Ultra-High Risk (UHR) of psychosis. Primary outcomes measure the severity of psychotic symptoms using the Comprehensive Assessment of At-Risk Mental States (CAARMS), tracked at multiple points from baseline through week 104. Secondary outcomes cover a range of psychological and health metrics, including depression (MADRS), anxiety (HAM-A, OASIS), sleep quality (PROMIS-SD), and general psychopathology (BPRS, NSI-PR). Functioning is measured with the Social and Occupational Functioning Assessment Scale (SOFAS), and quality of life is assessed with AQoL-8D, providing a comprehensive view of participants’ well-being. Data on adherence to the CBD regimen, adverse events (CTCAE), and cost-effectiveness (RUQ) are also included, with biomarker data from blood, urine, and hair samples to objectively monitor intervention effects.
Subjects
Mental Health / Psychosis and personality disorders / Ultra-High Risk of Psychosis
DOI Number
Date made available
Data are currently embargoed. They will be available after the main results have been published for an indefinite time.
Data set type
IPD
ANZCTR reference number
Publication
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Protocol
Researchers requiring more information regarding the study protocol are encouraged to contact the Principal Investigator via email.