ACTRN12624000236594尚未招募2 期
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:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 12 Years 至 25 Years(—)
- 性别
- All
入选标准
- •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).
排除标准
- •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.
研究者
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