Treating anxiety in young people (12-25 years) using Cannabidiol (CBD) when conventional anxiety treatments have proven ineffective.

Phase 2

• Conditions: Anxiety; Treatment-Resistant Anxiety; Mental Health - Anxiety

• Registration Number: ACTRN12624000236594
• Lead Sponsor: Orygen Centre for Youth Mental Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-03-11
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1.Aged 12-25 (inclusive) at entry;
2.Ability to give informed consent and adhere to study procedures (parental or guardian consent will be obtained for those aged <18 years);
3.Sufficient fluency in English (for assessment purposes);
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.Anxiety symptoms and functional impairment despite receiving TAU for at least 2 months, indicated by a score of greater than or equal to 10 on the OASIS, and lack of clinically meaningful improvement (CGI-I score = 2).

Exclusion Criteria

1.Prior sensitivity or allergy to cannabidiol (CBD) or any cannabis-derived product;
2.Current treatment with anxiolytic medication e.g. benzodiazepines or beta blockers;
3.If prescribed permitted psychotropic (e.g. antidepressant medication), the individual has not been on a stable dose for a minimum of 4 weeks;
4.Pregnancy, lactation, or if sexually active, no effective contraception;
5.Clinical blood test findings that might compromise participant safety or confound the trial results;
6.History of DSM-5 schizophrenia spectrum, delusional, bipolar I disorder, or current substance/medication induced psychotic disorder;
7.Acute or unstable systemic medical disorder;
8.Any metabolic, endocrine or other physical illness, e.g. thyroid disease, with neuropsychiatric consequences which may compromise the safety of the participant or the conduct of the trial;
9.Acute suicidality (indicated by a score of 3 on QIDS-A17-C item 13) or severe depression (indicated by a score of >20 on the QIDS-A17-C );
10.Severe disturbance, such that the person is unable to comply with either the requirements of informed consent or the treatment protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified