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大麻二酚(CBD)对慢性精神分裂症门诊患者认知功能和症状的影响:一项随机安慰剂对照试验。

The effects of cannabidiol (CBD) on cognition and symptoms in outpatients with chronic schizophrenia a randomized placebo controlled trial.

机构信息

Schizophrenia and Neuropharmacology Research Group at Yale, VA Connecticut Healthcare System, West Haven, CT, USA.

Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.

出版信息

Psychopharmacology (Berl). 2018 Jul;235(7):1923-1932. doi: 10.1007/s00213-018-4885-9. Epub 2018 Apr 5.

DOI:10.1007/s00213-018-4885-9
PMID:29619533
Abstract

RATIONALE

Preliminary evidence suggests that cannabidiol (CBD) may be effective in the treatment of neurodegenerative disorders; however, CBD has never been evaluated for the treatment of cognitive impairments associated with schizophrenia (CIAS).

OBJECTIVE

This study compared the cognitive, symptomatic, and side effects of CBD versus placebo in a clinical trial.

METHODS

This study was a 6-week, randomized, placebo-controlled, parallel group, fixed-dose study of oral CBD (600 mg/day) or placebo augmentation in 36 stable antipsychotic-treated patients diagnosed with chronic schizophrenia. All subjects completed the MATRICS Consensus Cognitive Battery (MCCB) at baseline and at end of 6 weeks of treatment. Psychotic symptoms were assessed using the Positive and Negative Syndrome Scale (PANSS) at baseline and biweekly.

RESULTS

There was no main effect of time or drug on MCCB Composite score, but a significant drug × time effect was observed (p = 0.02). Post hoc analyses revealed that only placebo-treated subjects improved over time (p = 0.03). There was a significant decrease in PANSS Total scores over time (p < 0. 0001) but there was no significant drug × time interaction (p = 0.18). Side effects were similar between CBD and placebo, with the one exception being sedation, which was more prevalent in the CBD group.

CONCLUSIONS

At the dose studied, CBD augmentation was not associated with an improvement in MCCB or PANSS scores in stable antipsychotic-treated outpatients with schizophrenia. Overall, CBD was well tolerated with no worsening of mood, suicidality, or movement side effects.

TRIAL REGISTRATION

https://clinicaltrials.gov/ct2/show/NCT00588731.

摘要

背景

初步证据表明,大麻二酚(CBD)可能对治疗神经退行性疾病有效;然而,CBD 从未被评估用于治疗精神分裂症相关的认知障碍(CIAS)。

目的

本研究在临床试验中比较了 CBD 与安慰剂治疗认知障碍、症状和副作用的效果。

方法

这是一项为期 6 周、随机、安慰剂对照、平行分组、固定剂量的研究,对 36 名稳定接受抗精神病药物治疗、诊断为慢性精神分裂症的患者进行了口服 CBD(600mg/天)或安慰剂增效治疗。所有患者在基线和 6 周治疗结束时均完成了 MATRICS 共识认知成套测验(MCCB)。在基线和每两周时使用阳性和阴性症状量表(PANSS)评估精神病症状。

结果

MCCB 综合评分无时间或药物的主效应,但观察到药物×时间的显著效应(p=0.02)。事后分析显示,只有安慰剂组随时间改善(p=0.03)。PANSS 总分随时间显著下降(p<0.0001),但药物×时间无显著交互作用(p=0.18)。CBD 和安慰剂组的副作用相似,只有镇静作用除外,CBD 组更为常见。

结论

在研究剂量下,CBD 增效治疗对稳定接受抗精神病药物治疗的精神分裂症门诊患者的 MCCB 和 PANSS 评分没有改善作用。总体而言,CBD 耐受性良好,没有情绪、自杀意念或运动副作用恶化的情况。

试验注册

https://clinicaltrials.gov/ct2/show/NCT00588731。

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