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临床试验/NCT02051387
NCT02051387已完成1 期

Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study With Approved Antipsychotics in Vivo

Central Institute of Mental Health, Mannheim2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
74
试验地点
2
主要终点
Plasma levels of cannabidiol

研究概览

简要总结

Despite recent advances in the understanding and treatment of schizophrenia, this devastating disease still affects one percent of world's population. Existing antipsychotics reduce psychotic symptoms but are generally not very effective in treating so called negative symptoms such as blunted affect and social withdrawal or cognitive disturbances due to the disease. Furthermore, a significant portion of patients is refractory to all current treatments. Therefore new treatment strategies are needed.

Several studies suggest a strong association between schizophrenia and the endocannabinoid system. This system mediates e.g. the pro-psychotic effects of the best-known ingredient of the cannabis plant - delta-tetrahydrocannabinol (Δ9-THC). While the pro-psychotic Δ9-THC is known to abet the onset of schizophrenia, another, non-psychotomimetic plant ingredient - cannabidiol - has recently been shown to exert antipsychotic effects similar to those of one of the most effective modern antipsychotics, amisulpride, but it induced significantly less side effects.

In this phase I safety study, the investigators will evaluate the pharmacokinetics, pharmacoequivalence, and drug-drug interaction profile with current antipsychotics of a new tablet pharmaceutical preparation of cannabidiol in healthy volunteers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Informed consent given by the subject
  • Both, female and male subjects may participate
  • Age between 18 and 45
  • Negative drug screening at the time of screening
  • Non-smoking
  • In female participants in fertile age, reliable contraception, which means contraception's pearl-index is equal or smaller than
  • Body Mass Index between 18 and 30

排除标准

  • Lack of accountability
  • Any current psychiatric disorder through the Structured Clinical Interview for DSM-IV (SCID) at the time of screening
  • Pregnancy or lactation phase in female at the time of screening
  • Any known psychiatric or neurological illness in the participant's history.
  • Known family history concerning psychiatric disorders
  • Relevant use of cannabis (which is defined on the present state of knowledge as at the most five times lifetime-consumption and no consumption for at least one year)
  • Severe physical (internal) or neurological illness, especially cardiovascular, renal, advanced respiratory, haematological or endocrinological failures or infectious diseases (acute hepatitis A, B or C or HIV) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, at the discretion of the investigator
  • Consumption of any illicit drugs (except cannabis in history, see above)

研究组 & 干预措施

Quetiapine and Cannabidiol CR

Experimental

Interaction between Quetiapine and Cannabidiol CR

干预措施: Quetiapine (Drug)

Risperidone and Cannabidiol CR

Experimental

Interaction between Risperidone and Cannabidiol CR

干预措施: Cannabidiol CR (Drug)

Risperidone and Cannabidiol CR

Experimental

Interaction between Risperidone and Cannabidiol CR

干预措施: Risperidone (Drug)

Amisulpride and Cannabidiol CR

Experimental

Interaction between Amisulpride and Cannabidiol CR

干预措施: Cannabidiol CR (Drug)

Amisulpride and Cannabidiol CR

Experimental

Interaction between Amisulpride and Cannabidiol CR

干预措施: Amisulpride (Drug)

Olanzapine and Cannabidiol CR

Experimental

Interaction between Olanzapine and Cannabidiol CR

干预措施: Cannabidiol CR (Drug)

Olanzapine and Cannabidiol CR

Experimental

Interaction between Olanzapine and Cannabidiol CR

干预措施: Olanzapine (Drug)

Quetiapine and Cannabidiol CR

Experimental

Interaction between Quetiapine and Cannabidiol CR

干预措施: Cannabidiol CR (Drug)

Cannabidiol

Active Comparator

Cannabidiol capsule, 200 mg single dose

干预措施: Cannabidiol (Drug)

Cannabidiol CR

Experimental

Cannabidiol tablet, various dosages

干预措施: Cannabidiol CR (Drug)

Cannabidiol CR and Placebo

Placebo Comparator

Cannabidiol CR levels without interaction with antipsychotics

干预措施: Cannabidiol CR (Drug)

Cannabidiol CR and Placebo

Placebo Comparator

Cannabidiol CR levels without interaction with antipsychotics

干预措施: Placebo (Drug)

结局指标

主要结局

Plasma levels of cannabidiol

时间窗: up to 10 days

次要结局

  • serum antipsychotic concentration(baseline and after seven days)
  • Area Under Curve (AUC)(up to 10 days)

研究者

发起方
Central Institute of Mental Health, Mannheim
申办方类型
Other
责任方
Sponsor

研究点 (2)

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