ANZCTR - Registration

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12617000825358

Ethics application status

Approved

Date submitted

18/05/2017

Date registered

6/06/2017

Date last updated

18/07/2024

Date data sharing statement initially provided

6/05/2019

Date results provided

19/06/2024

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]

Nil known.

Universal Trial Number (UTN)

Trial acronym

CAPS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anxiety

Condition category

Condition code

Mental Health

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]

Treatment: Drugs

Intervention code [2]

Treatment: Other

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Week 12

Secondary outcome [1]

Diagnosis of an anxiety disorder, as diagnosed by the Structured Clinical Interview for DSM-5.

Timepoint [1]

Week 12

Secondary outcome [2]

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]

Week 12

Secondary outcome [3]

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]

Week 12

Secondary outcome [4]

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]

Week 12

Secondary outcome [5]

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]

Week 12

Secondary outcome [6]

The Cannabis Withdrawal Scale (CWS) assess any symptoms of withdrawal as the study medication is ceased.

Timepoint [6]

Weeks 13

Secondary outcome [7]

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]

Week 12

Secondary outcome [8]

Serious AEs (SAEs), assessed with non-leading questions. Known SAEs include convulsion.

Timepoint [8]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

16/05/2018

Actual

25/05/2018

Date of last participant enrolment

Anticipated

Actual

28/06/2019

Date of last data collection

Anticipated

31/12/2019

Actual

24/09/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Headspace Glenroy - Glenroy

Recruitment postcode(s) [1]

3046 - Glenroy

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

The Lambert Initiative for Cannabinoid Therapeutics

Address [1]

The University of Sydney
Camperdown, NSW 2050

Country [1]

Australia

Funding source category [2]

Other

Name [2]

Orygen, The National Centre for Excellence in Youth Mental Health

Address [2]

35 Poplar Road
Parkville, VIC 3052

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry Ltd.

Ethics committee address [1]

129 Glen Osmond Road 
Eastwood, SA 5063

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/05/2017

Approval date [1]

05/09/2017

Ethics approval number [1]

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

Prof G. Paul Amminger

Address

Orygen, 35 Poplar Road, Parkville, VIC 3052

Country

Australia

Phone

+61 0399669100

Fax

paul.amminger@orygen.org.au

Contact person for public queries

Name

Paul Amminger

Address

Orygen, 35 Poplar Road, Parkville, VIC 3052

Country

Australia

Phone

+61 0399669100

Fax

paul.amminger@orygen.org.au

Contact person for scientific queries

Name

G. Paul Amminger

Address

Orygen, 35 Poplar Road, Parkville, VIC 3052

Country

Australia

Phone

+61 0399669100

Fax

paul.amminger@orygen.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All data, anonymised.

When will data be available (start and end dates)?

Data are available immediately for an indefinite time.

Available to whom?

Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data management policy.

Available for what types of analyses?

To any type of analyses. Assessed on a case-by-case basis

How or where can data be obtained?

Access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health). Search for the ANZTRN number in the catalogue to find datasets associated with this trial.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Cannabidiol for Treatment-Resistant Anxiety Disorders in Young People: An Open-Label Trial.	2022	https://dx.doi.org/10.4088/JCP.21m14130

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Did you know?

Documents added manually

Documents added automatically