None listed
Conditions
Brief summary
Affecting 15% of youth, anxiety disorders are among the most prevalent psychiatric conditions in adolescents in Australia. These disorders are associated with significant morbidity and risk of suicide attempts and predict a range of psychiatric conditions later in life. Current treatments for anxiety disorders in this age group include cognitive-behaviour therapy and/or medication. However, only 50% of young patients with anxiety disorders show satisfactory improvements with these treatments. CBD is one of several components of the plant Cannabis sativa, Unlike other substances found in this plant, CBD is devoid of psychotropic effects (i.e. alterations in thinking and perception). There is evidence from experimental studies that CBD is safe in humans and effective in reducing anxiety in healthy volunteers (e.g. in simulated public speaking tasks). A systematic review of potential side effects in humans found that CBD was well tolerated across a wide dose range, up to 1500 mg/day. However, CBD has not been tested in young people with anxiety disorders. The aim of the present study is to produce preliminary evidence for the safety and anxiolytic effects of CBD in youth with anxiety disorders. This is a single-centre, 12-week open label trial of CBD in patients aged 12-25 (inclusive) who do not respond to current treatments for anxiety disorders. All patients included into the study will receive CBD on a fixed-flexible schedule, beginning with 200mg of CBD per day, which can be adjusted up to 800mg/day for participants who tolerate CBD. The study will be conducted at a headspace centre funded through the Commonwealth Government of Australia. The headspace centre is located in the suburb of Glenroy, Orygen manages the clinical governance of this headspace site. Headspace centres focus both on youth mental health and early intervention, young people may present for care with varying illness severity (e.g. sub-threshold through to severe disorder, and mild to severely impaired functioning) across a range of mental health problems
Interventions
Experimental intervention: All participants will receive open-label cannabidiol (CBD) for 12 weeks.
Background intervention: All participants will be offered biweekly cognitive-behaviour therapy (CBT) for 12 weeks (5 sessions). CBT will be administered as one-on-one sessions (1hr) by a qualified clinician at the study site (one of four headspace centres).
CBD will be administered on a fixed–flexible schedule beginning with 200 mg (oral capsule) per day and adjusted up to 800 mg per day by we
Experimental intervention: All participants will receive open-label cannabidiol (CBD) for 12 weeks. Background intervention: All participants will be offered biweekly cognitive-behaviour therapy (CBT) for 12 weeks (5 sessions). CBT will be administered as one-on-one sessions (1hr) by a qualified clinician at the study site (one of four headspace centres). CBD will be administered on a fixed–flexible schedule beginning with 200 mg (oral capsule) per day and adjusted up to 800 mg per day by week 8. Until week 8, participants who are considered to have failed to improve using the CGI-I (operationalised as a score of >=3) and who are tolerating the medication are eligible for dose increases at each assessment. Dose escalation can occur with 200 mg/day increments, with at least a 4-week gap between dose increments, except for the first dose increase (200mg/day to 400mg/day), which can occur at the end of week 1 after tolerance of the initial dose of the study medication has been established. Participants who receive 400mg/day after week 1 are also eligible for the next dose increase at week 4. Adherence to the trial medication will be assessed by pill count.
Sponsors
Orygen, The National Centre for Excellence in Youth Mental Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
12 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
(1) age 12-25 inclusive; (2) ability to give informed consent and adhere to study procedures (parental or guardian consent will be obtained for those under the age of 18); (3) sufficient fluency in English; (4) diagnosis of a DSM-5 anxiety disorder (i.e., social anxiety disorder, panic disorder, separation anxiety disorder, specific phobia, agoraphobia, generalized anxiety disorder); (5) failure to show substantial, clinically meaningful improvement in anxiety severity during the last 8 to 16 weeks of CBT (minimum of 5 sessions), indicated by a score of 3 or higher on the Clinical Global Impression–Improvement scale (the CGI rating will be provided by the CBT therapist)
Exclusion criteria
(1) DSM-5 schizophrenia spectrum disorder, delusional disorder, bipolar I disorder, substance/medication induced psychotic disorder; (2) prior sensitivity or allergy to CBD or any cannabis-derived product; (3) current treatment with antipsychotic medication, anxiolytic medication or mood stabiliser; or any medication that either interacts with the metabolism of CBD or is affected by CBD and in the view of the study doctor cannot be co-administered safely (4) if prescribed antidepressive medication, the individual must have been on a stable and sufficient dose for a minimum of 6 weeks; (5) pregnancy, lactation, or if sexually active, no effective contraception; (6) haematological findings that result in medically significant liver, thyroid or other conditions (7) acute or unstable systemic medical disorder; (8) psychiatric condition due to a medical condition; (9) acute suicidality (10) previous or current severe drug or severe alcohol dependence; (11) severe disturbance, such that the person is unable to comply with either the requirements of informed consent or the treatment protocol (6) haematological findings that result in medically significant liver, thyroid or other conditions (9) acute suicidality (10) previous or current severe drug or severe alcohol dependence;
Outcome results
None listed