Efficacy Of Cannabidiol For Youth With Inadequate Clinical <br>Response To Anxiety Treatments: A Randomised <br>Controlled Trial
Funder
MRFF
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 yout ....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.Read moreRead less
RIGHT HERE, RIGHT NOW. A National Survey Examining Social Determinants And Risk And Protective Factors For Mental Illness, Suicidal Ideation And Self-harm In Young Australians
Funder
MRFF
Summary
This MRFF-funded project seeks to understand what is driving worsening mental health, self-harm and suicidal ideation in young people across Australia, and to offer potential solutions. Specifically, this project seeks to answer the following broad research questions:
What are the social determinants and broad protective factors associated with mental ill-health, suicidal ideation and self-harm in young Australians?
What are the individual-level/ proximal risk and protective factors associat ....This MRFF-funded project seeks to understand what is driving worsening mental health, self-harm and suicidal ideation in young people across Australia, and to offer potential solutions. Specifically, this project seeks to answer the following broad research questions:
What are the social determinants and broad protective factors associated with mental ill-health, suicidal ideation and self-harm in young Australians?
What are the individual-level/ proximal risk and protective factors associated with mental ill-health, suicidal ideation and self-harm and how do these fluctuate in the short term?
What macro-level policies and individual-level interventions are most likely to reduce mental ill-health, suicidal ideation and self-harm in young Australians over the near-to-medium term?
The project involves three distinct studies:
A national survey to investigate the social determinants and protective factors associated with mental ill health, suicidal ideation and self-harm in young people. Recruitment (n=3000) for this component will be managed through the Roy Morgan consumer panel and respondent database, as well as third party suppliers.
A multi-site EMA (ecological momentary assessment) study to collect real-time data on the in-the-moment risk and protective factors for mental ill health, suicidal ideation and self-harm in young people. These participants (n=100) will be drawn from the larger pool of survey respondents, with the study to be conducted over three sites (Vic, ACT and NSW) in 2024.
A modelling study to identify which interventions are likely to have the most impact on mental ill-health, suicidal ideation and self-harm among young Australians based on dynamic systems modelling of data from studies 1 and 2. The model will harness systems thinking and modelling, simulation and data assimilation to deliver an interactive decision support infrastructure tool to inform policy development, service planning and implementation at both a national and regional level. Read moreRead less
Validating Cognitive Screening In Young People With First-episode Psychosis (CogScreen)
Funder
MRFF
Summary
Aim: Cognitive impairments are a core feature of first-episode psychosis (FEP) and one of the strongest predictors of long-term psychosocial functioning. Cognition should be assessed and treated as part of routine clinical care for FEP. Cognitive screening offers the opportunity to rapidly identify and triage those in most need of cognitive support. However, there are currently no validated screening measures for young people with FEP. CogScreen is a hybrid effectiveness-implementation study whi ....Aim: Cognitive impairments are a core feature of first-episode psychosis (FEP) and one of the strongest predictors of long-term psychosocial functioning. Cognition should be assessed and treated as part of routine clinical care for FEP. Cognitive screening offers the opportunity to rapidly identify and triage those in most need of cognitive support. However, there are currently no validated screening measures for young people with FEP. CogScreen is a hybrid effectiveness-implementation study which aims to evaluate the classification accuracy (relative to a neuropsychological assessment as a reference standard), test–retest reliability and acceptability of two cognitive screening tools in young people with FEP. Methods: Participants will be 350 young people (aged 12–25) attending primary and specialist FEP treatment centres in three large metropolitan cities (Adelaide, Sydney, and Melbourne) in Australia. All participants will complete a cross-sectional assessment over two sessions including two cognitive screening tools (Screen for Cognitive Impairment in Psychiatry and Montreal Cognitive Assessment), a comprehensive neuropsychological assessment battery, psychiatric and neurodevelopmental assessments, and other supplementary clinical measures. To determine the test–retest reliability of the cognitive screening tools, a subset of 120 participants will repeat the screening measures two weeks later.Read moreRead less
RIGHT HERE, RIGHT NOW. An Ecological Momentary Assessment (EMA) Study To Understand Risk And Protective Factors For Mental Ill Health, Suicidal Ideation And Self-harm In Young People
Funder
MRFF
Summary
This MRFF-funded project seeks to understand what is driving worsening mental health, self-harm and suicidal ideation in young people across Australia, and to offer potential solutions. Specifically, this project seeks to answer the following broad research questions:
What are the social determinants and broad protective factors associated with mental ill-health, suicidal ideation and self-harm in young Australians?
What are the individual-level/ proximal risk and protective factors associat ....This MRFF-funded project seeks to understand what is driving worsening mental health, self-harm and suicidal ideation in young people across Australia, and to offer potential solutions. Specifically, this project seeks to answer the following broad research questions:
What are the social determinants and broad protective factors associated with mental ill-health, suicidal ideation and self-harm in young Australians?
What are the individual-level/ proximal risk and protective factors associated with mental ill-health, suicidal ideation and self-harm and how do these fluctuate in the short term?
What macro-level policies and individual-level interventions are most likely to reduce mental ill-health, suicidal ideation and self-harm in young Australians over the near-to-medium term?
The project involves three distinct studies:
A national survey to investigate the social determinants and protective factors associated with mental ill health, suicidal ideation and self-harm in young people. Recruitment (n=3000) for this component will be managed through the Roy Morgan consumer panel and respondent database, as well as third party suppliers.
A multi-site EMA (ecological momentary assessment) study to collect real-time data on the in-the-moment risk and protective factors for mental ill health, suicidal ideation and self-harm in young people. These participants (n=100) will be drawn from the larger pool of survey respondents, with the study to be conducted over three sites (Vic, ACT and NSW) in 2024.
A modelling study to identify which interventions are likely to have the most impact on mental ill-health, suicidal ideation and self-harm among young Australians based on dynamic systems modelling of data from studies 1 and 2. The model will harness systems thinking and modelling, simulation and data assimilation to deliver an interactive decision support infrastructure tool to inform policy development, service planning and implementation at both a national and regional level. Read moreRead less