Cannabidiol for at risk for psychosis youth: A randomized controlled trial
Cannabidiol for at risk for psychosis youth: A randomized controlled trial
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DOI：
10.1111/eip.13182
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发表时间：
2021-06-30
影响因子：
2
通讯作者：
McGorry, Patrick D.
中科院分区：
文献类型：
--
作者：
Amminger, G. Paul;Lin, Ashleigh;McGorry, Patrick D.
背景：对于处于危险期的精神障碍，目前还没有确定的生物治疗方法。在这项研究中，我们的目的是测试是否可以有效地治疗阈下精神病症状与大麻二酚（CBD），植物大麻的非精神活性化合物。在有证据质疑精神病超高风险（UHR）人群中特定药物干预的必要性和有效性之后，这个问题变得越来越重要。方法采用三组随机对照试验，对405例符合UHR精神病诊断标准的12-25岁患者进行研究。该研究包括一个为期6周的导入期，在此期间，预计10%的UHR个体将经历症状缓解。参与者将接受CBD（口服），剂量为每天600或1000 mg（固定时间表），持续12周。试验第三组的受试者将接受匹配的安慰剂胶囊。主要结局是12周时通过高危精神状态综合评估测量的阳性精神病症状的严重程度。我们假设CBD在改善UHR患者的阳性精神病症状方面比安慰剂更有效。所有参与者还将在基线后6个月进行随访，以评估治疗效果是否持续。结论本文报告了大麻二酚对精神病风险青年（CanARY）研究的基本原理和方案。这项研究将首次在精神障碍的UHR阶段测试CBD。
Background No biological treatment has been firmly established for the at-risk stage of psychotic disorder. In this study we aim to test if subthreshold psychotic symptoms can be effectively treated with cannabidiol (CBD), a non-psychoactive compound of the plant Cannabis sativa. The question has taken on increased importance in the wake of evidence questioning both the need and efficacy of specific pharmacological interventions in the ultra-high risk (UHR) for psychosis group. Methods Three-arm randomized controlled trial of 405 patients (135 per arm) aged 12-25 years who meet UHR for psychosis criteria. The study includes a 6-week lead-in phase during which 10% of UHR individuals are expected to experience symptom remission. Participants will receive CBD (per oral) at doses 600 or 1000 mg per day (fixed schedule) for 12 weeks. Participants in the third arm of the trial will receive matching placebo capsules. Primary outcome is severity of positive psychotic symptoms as measured by the Comprehensive Assessment of At-Risk Mental States at 12 weeks. We hypothesize that CBD will be significantly more effective than placebo in improving positive psychotic symptoms in UHR patients. All participants will also be followed up 6 months post baseline to evaluate if treatment effects are sustained. Conclusion This paper reports on the rationale and protocol of the Cannabidiol for At Risk for psychosis Youth (CanARY) study. This study will test CBD for the first time in the UHR phase of psychotic disorder.