Efficacy of Cannabidiol for Youth with Inadequate Clinical Response to Anxiety Treatments - A Randomised Controlled Trial

Orygen Centre for Youth Mental Health0 个研究点目标入组 180 人开始时间: 2024年3月11日最近更新: 2024年3月18日

适应症

试验速览

暂无简介。

•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).

•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.

发起方

Orygen Centre for Youth Mental Health