A Four-week, Multicentre, Double-blinded, Randomised, Active- and Placebo- Controlled, Parallel-group Trial Investigating Efficacy and Safety of Cannabidiol in Acute, Early-stage Schizophrenic Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Change in the Positive and Negative Syndrome Scale (PANSS) total score
研究概览
简要总结
Schizophrenia is a heterogeneous mental disorder that affects one percent of the world's population. Current antipsychotics are only partially effective, and their use is often associated with serious side effects. Cannabidiol is a natural counterpart of the psychoactive component of marijuana, delta-9-tetrahydrocannabinol. While cannabidiol has no psychotomimetic or addictive properties, it indirectly affects endogenous cannabinoid signalling by impairing the degradation of the endocannabinoid anandamide. In a controlled clinical trial of cannabidiol versus amisulpride (an established antipsychotic) in acute paranoid schizophrenics the investigators showed a significant clinical improvement in all symptoms of schizophrenia compared to baseline with either treatment. But cannabidiol displayed a significantly superior side-effect profile. This study is to evaluate the efficacy and safety of this novel treatment option in comparison to placebo and olanzapine, an established second generation antipsychotic in the treatment of acute schizophrenia and schizophrenia maintenance therapy, in a four-week clinical trial.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent given by the subject
- •DSM-IV-TR diagnosis of schizophrenic psychosis (295.10, 295.20, 295.30, 295.90 (American Psychiatric Association)
- •Patients must be within the first three years of illness, i.e. first diagnosis of schizophrenia is no older than three years.
- •Age 18 to 65 years, male or female
- •Minimal initial PANSS score of 75 at baseline
- •Female patients of childbearing potential need to utilize a proper method of contraception.
- •Body Mass Index between 18 and 40
排除标准
- •Lack of accountability (assessed by an independent psychiatrist)
- •History of treatment-resistant schizophrenia, defined as no response to at least two antipsychotics given for a minimum of 6 weeks each in an adequate dosage
- •Positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines)
- •Serious suicidal risk at screening visit (Subject to investigator's and independent psychiatrist's judgement: Poses a serious suicidal or homicidal risk at screening visit or has made a serious suicide attempt within the last 12 months prior to screening visit, or has exhibited homicidal behaviour at anytime during her/his lifetime)
- •Known intolerance or allergy to olanzapine or cannabidiol
- •Other relevant interferences of axis 1 (e.g. serious depression) according to diagnostic evaluation (MINI) including residual forms of schizophrenia
- •Pregnancy, as determined through a β-HCG pregnancy test, or lactation
研究组 & 干预措施
Cannabidiol
Cannabidiol capsules 2x200 mg twice a day and placebo olanzapine capsule once a day over 4 weeks
干预措施: Cannabidiol (Drug)
Cannabidiol
Cannabidiol capsules 2x200 mg twice a day and placebo olanzapine capsule once a day over 4 weeks
干预措施: Placebo Olanzapine (Drug)
Olanzapine
Olanzapine capsule 15mg once a day and placebo cannabidiol capsules twice a day over 4 weeks
干预措施: Olanzapine (Drug)
Olanzapine
Olanzapine capsule 15mg once a day and placebo cannabidiol capsules twice a day over 4 weeks
干预措施: Placebo Cannabidiol (Drug)
Placebo
Placebo cannabidiol capsules twice a day and placebo olanzapine capsule once a day over 4 weeks
干预措施: Placebo Cannabidiol (Drug)
Placebo
Placebo cannabidiol capsules twice a day and placebo olanzapine capsule once a day over 4 weeks
干预措施: Placebo Olanzapine (Drug)
结局指标
主要结局
Change in the Positive and Negative Syndrome Scale (PANSS) total score
时间窗: within 4 weeks
次要结局
- Response to antipsychotic medication(within 4 weeks)
- Changes in physiological parameter(within 4 weeks)
- Changes in the Personal and Social Performance Scale(within 4 weeks)
- Changes in the UKU Side Effect Rating Scale(within 4 weeks)
- Changes in the Global Assessment of Functioning Scale(within 4 weeks)
- Changes in the Clinical Global Impression score(within 4 weeks)
- Changes in the Hamilton Anxiety Scale(within 4 weeks)
- Changes in cognitive skills(within 4 weeks)
- Columbia Suicidality Severity Rating Scale(within 4 weeks)
- Changes in the PANSS subscores and clusters(within 4 weeks)
- Changes in the Calgary Depression Scale for Schizophrenia(within 4 weeks)
- Plasma levels of endogenous cannabinoids(within 4 weeks)