Efficacy of Cannabidiol for Youth with Inadequate Clinical <br>Response to Anxiety Treatments: A Randomised <br>Controlled Trial

Funded Activity Summary

Anxiety disorders are the most prevalent psychiatric conditions in adolescents, affecting around 8% of young people in Australia1. They can disrupt the developmental trajectories, and the rate of treatment resistance and corresponding functional impairment is high. Treatments for anxiety disorders include cognitive behavioural therapy (CBT) and selective serotonin-reuptake inhibitors/selective serotonin–norepinephrine reuptake inhibitors (SSRIs/SSNRIs). Meta-analyses indicate that 40-50% of youth with anxiety disorders do not respond to CBT or SSRIs/SSNRIs2,3. The use of medications is also limited by treatment-emergent disinhibition, irritability, hyperactivity, impulsivity, insomnia, sexual dysfunction and suicidality, thereby making them unacceptable for young people2. Thus, there is a compelling need to explore novel agents for the treatment of anxiety disorders in this age group. Cannabidiol (CBD), a main component of Cannabis, can effectively reduce anxiety in adults with social anxiety disorder with comparable efficacy to benzodiazepines4. Importantly, CBD has recently been used in one open label study and one randomised placebo-controlled trial (RCT) in childhood epilepsy and found to be safe and well tolerated in children and adolescents5. The minimal side effects and the high margin of safety, coupled with an emerging therapeutic profile of CBD6, support the current investigation of its potential as a novel intervention for youth with treatment-resistant anxiety. Pilot study: We tested CBD up to 800 mg/day for 12 weeks in 31 individuals (mean age=21.1) with treatment resistant anxiety disorders. Two-thirds of participants had a >33% reduction in anxiety severity and 40% of participants had >50% reduction at 12 weeks. CBD was well tolerated with no severe, or unexpected adverse events; 94% of participants completed the intervention, indicating high acceptability. Aim: To investigate whether CBD can reduce anxiety severity in youth with anxiety disorders aged 12 to 25 presenting to a headspace service who have failed to respond to CBT or SSRIs/SSNRIs. Primary hypothesis: Compared with placebo, youth with anxiety disorders treated with CBD will show significantly greater improvement from baseline in anxiety severity at the 12-week endpoint. Participants: 180 patients (90 per arm) aged 12-25 years with an anxiety disorder who have failed to show clinically meaningful improvement (CGI-I score ≥ 3) in response to CBT or SSRIs/SSNRIs. Intervention: CBD (per oral) – doses of 400-800 mg/day (fixed-flexible schedule) for 12 weeks. Primary outcome: Improvement in anxiety severity (OASIS) at 12 weeks. Predictive biomarkers: Blood parameters; plasma cannabinoid levels. Partners: The Lambert Initiative for Cannabinoid Therapeutics at the University of Sydney is a long-term research program devoted to the science of cannabinoids and the discovery and development of cannabis-based medicines. Other partners on this proposal, Orygen, headspace and Youthfocus, put young people at the centre of the research that is undertaken, the way in which research is conducted and disseminated. Partnerships with consumers from these organisations will facilitate active youth participation for trial design, research translation and rapid dissemination.

Funded Activity Details

Start Date: 01-01-2022

End Date: 01-01-2026

Funding Scheme: Funding Scheme not available

Funder: MRFF

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