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Trial registered on ANZCTR


Registration number
ACTRN12617000825358
Ethics application status
Approved
Date submitted
18/05/2017
Date registered
6/06/2017
Date last updated
19/11/2019
Date data sharing statement initially provided
6/05/2019
Date results information initially provided
19/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The cannabidiol youth anxiety pilot study (CAPS): a 12-week open- label pilot study of cannabidiol for anxiety disorders
Scientific title
The cannabidiol youth anxiety pilot study (CAPS): a 12-week open- label pilot study of the safety, tolerability and efficacy of cannabidiol for anxiety disorders
Secondary ID [1] 291931 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
CAPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 303295 0
Condition category
Condition code
Mental Health 302723 302723 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 298073 0
Treatment: Drugs
Intervention code [2] 298074 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302118 0
Anxiety severity after 12 weeks, measured on the Overall Anxiety Severity and Impairment Scale (OASIS). Total scores on this scale range from 0-20.
Timepoint [1] 302118 0
Week 12
Secondary outcome [1] 334849 0
Diagnosis of an anxiety disorder, as diagnosed by the Structured Clinical Interview for DSM-5.
Timepoint [1] 334849 0
Week 12
Secondary outcome [2] 334850 0
The Clinical Global Impression–Improvement (CGI-I) scale, which ranges from 1 to 7, with lower scores indicating more improvement, as compared with baseline. A score of 1 or 2 reflects a substantial, clinically meaningful improvement in anxiety severity.
Timepoint [2] 334850 0
Week 12
Secondary outcome [3] 334851 0
The Hamilton Anxiety Rating (HAM-A) is is one of the most used composite rating scales to measure anxiety in both clinical and research settings. It is clinician-rated and consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).
Timepoint [3] 334851 0
Week 12
Secondary outcome [4] 334852 0
The Quick Inventory Depression Symptomatology (QIDS) assesses the criterion symptom domains for DSM-5 major depressive disorder. The scale has been shown to be a reliable tool for assessing adolescent depression, making it one of the few depression scales that has been validated across adolescent and adult populations.
Timepoint [4] 334852 0
Week 12
Secondary outcome [5] 334853 0
The Social and Occupational Functional Assessment Scale (SOFAS) is a widely-used global rating of current functioning, ranging from 0 to 100, with lower scores representing lower functioning.
Timepoint [5] 334853 0
Week 12
Secondary outcome [6] 334854 0
The Cannabis Withdrawal Scale (CWS) assess any symptoms of withdrawal as the study medication is ceased.
Timepoint [6] 334854 0
Weeks 13
Secondary outcome [7] 334911 0
Adverse events (AEs), assessed with non-leading questions. Known AEs of CBD include sleepiness/mild sedation, decreased or increased appetite, diarrhea and fatigue.
Timepoint [7] 334911 0
Week 12
Secondary outcome [8] 335553 0
Serious AEs (SAEs), assessed with non-leading questions. Known SAEs include convulsion.
Timepoint [8] 335553 0
Week 12

Eligibility
Key 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)
Minimum age
12 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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;

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Open-label study.
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The main analysis will be based on all enrolled participants with at least one post-baseline observation (intention-to-treat population). The primary efficacy analysis will assess average differences for the primary outcome measure (OASIS total score) over the entire study period and will use a likelihood based mixed-effects model, repeated measures approach (MMRM).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8034 0
Headspace Glenroy - Glenroy
Recruitment postcode(s) [1] 16005 0
3046 - Glenroy

Funding & Sponsors
Funding source category [1] 296435 0
Charities/Societies/Foundations
Name [1] 296435 0
The Lambert Initiative for Cannabinoid Therapeutics
Address [1] 296435 0
The University of Sydney
Camperdown, NSW 2050
Country [1] 296435 0
Australia
Funding source category [2] 296461 0
Other
Name [2] 296461 0
Orygen, The National Centre for Excellence in Youth Mental Health
Address [2] 296461 0
35 Poplar Road
Parkville, VIC 3052
Country [2] 296461 0
Australia
Primary sponsor type
Other
Name
Orygen, The National Centre for Excellence in Youth Mental Health
Address
35 Poplar Road
Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 295417 0
None
Name [1] 295417 0
Address [1] 295417 0
Country [1] 295417 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297668 0
Bellberry Ltd.
Ethics committee address [1] 297668 0
129 Glen Osmond Road
Eastwood, SA 5063
Ethics committee country [1] 297668 0
Australia
Date submitted for ethics approval [1] 297668 0
12/05/2017
Approval date [1] 297668 0
05/09/2017
Ethics approval number [1] 297668 0
2017-02-107

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74754 0
Prof G. Paul Amminger
Address 74754 0
Orygen, The National Centre of Excellence in Youth Mental Health
35 Poplar Road (Locked Bag 10)
Parkville, VIC 3052
Country 74754 0
Australia
Phone 74754 0
+61 3 9342 2800
Fax 74754 0
Email 74754 0
paul.amminger@orygen.org.au
Contact person for public queries
Name 74755 0
Dr Emily Li
Address 74755 0
Orygen, The National Centre of Excellence in Youth Mental Health
35 Poplar Road (Locked Bag 10)
Parkville, VIC 3052
Country 74755 0
Australia
Phone 74755 0
+61 3 9342 2800
Fax 74755 0
Email 74755 0
emily.li@orygen.org.au
Contact person for scientific queries
Name 74756 0
Prof G. Paul Amminger
Address 74756 0
Orygen, The National Centre of Excellence in Youth Mental Health
35 Poplar Road (Locked Bag 10)
Parkville, VIC 3052
Country 74756 0
Australia
Phone 74756 0
+61 3 9342 2800
Fax 74756 0
Email 74756 0
paul.amminger@orygen.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Currently no plan to publicly share IPD.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary