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临床试验/NCT03608137
NCT03608137终止不适用

Cannabis and Thought Disorder in Schizophrenia: Clinical and Neuroimaging Relationships

Hôpital le Vinatier2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2018年12月7日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
63
试验地点
2
主要终点
Level of thought disorder

研究概览

简要总结

Recent studies have suggested a strong relationship between cannabis use and the level of thought disorder in subjects with schizophrenia. Moreover, the level of thought disorder has been associated with an increased functional connectivity between the temporal lobe and the Putamen. However, the brain mechanisms underlying these two relationships are still poorly known. Better understanding these mechanisms is important to improve patients' care, in particular among treatment-resistant patients.

The objective of the CANDI study consists of assessing whether the level of cannabis use in patients with schizophrenia modulates the level of thought disorder via a modulation of the functional connectivity between the temporal lobe and the Putamen. Analyses will be controlled for the composition of cannabis, in particular the tetrahydrocannabinol / cannabidiol ratio.

详细描述

25 subjects with schizophrenia and current cannabis use will be recruited in the experimental group. The control group will consist of 25 subjects with schizophrenia but with no cannabis use.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 18 and 65
  • Meeting the DSM-5 criteria for schizophrenia
  • "Cannabis user" group: - Smoking at least two days per week during the previous months
  • Displaying positive urine screen for cannabis
  • "Non-cannabis user" group: - No episode of cannabis smoking during the previous month
  • Negative urine screen for cannabis + no lifetime criteria for cannabis use disorder (assessment by an addiction specialist).

排除标准

  • Current criteria for axis-1 psychiatric disorder other than schizophrenia
  • Current criteria for any other substance use disorder except for nicotine use disorder
  • Any contraindication for MRI
  • Tutorship or curatorship
  • Pregnant or lactating woman

结局指标

主要结局

Level of thought disorder

时间窗: one year

The level of thought disorder will be investigated using the specific items of the Positive And Negative Syndrome Scale (PANSS; Kay et al., 1987) Minimum score 1 Maximum score 7

次要结局

  • cannabis use(one year)
  • Delta-9 tetrahydrocannabinol (THC) concentration(one year)
  • Cannabidiol (CBD) concentration(one year)

研究者

发起方
Hôpital le Vinatier
申办方类型
Other
责任方
Sponsor

研究点 (2)

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Cannabis and Thought Disorder in Schizophrenia | 临床试验