Enhancing Recovery in Early Schizophrenia - a Multi-center, Two-arm, Double-blind, Randomized Phase II Trial Investigating Cannabidiol vs. Placebo as an add-on to an Individualized Antipsychotic Treatment
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
- 试验地点
- 6
- 主要终点
- All-cause discontinuation
研究概览
简要总结
Current antipsychotic treatments of schizophrenia 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 and has no psychotomimetic or addictive properties. In a controlled clinical trial of cannabidiol versus amisulpride in acute paranoid schizophrenia we showed a statistically significant clinical improvement in all symptoms clusters of schizophrenia compared to baseline with either treatment. Cannabidiol displayed a significantly superior side-effect profile in particular regarding prolactin elevation, extrapyramidal symptoms and weight gain. The favorable side-effect profile and potentially novel mechanism of action identify this molecule as a potential antipsychotic. However, long-term safety and efficacy data is still lacking. This study is to evaluate the efficacy and safety of the novel compound cannabidiol in the maintenance treatment of schizophrenia in comparison to placebo as an add-on to an established treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone, in a 12-months, double-blind, parallel-group, randomized, placebo-controlled clinical trial. Thereby, relevant data on cannabidiol's antipsychotic potential will be gained.
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 (295.10-30, 295.90)
- •First documented diagnosis of schizophrenia must not be no older than seven years.
- •Patients must receive a stable dose of amisulpride, aripiprazole, olanzapine, quetiapine or risperidone (TAU: treatment as usual) at least 4 weeks prior to inclusion in the study to ensure that the maximal effect of the previous medication has been received.
- •Initial PANSS total score of ≤ 75 at baseline.
- •proper contraception in female patients of childbearing potential
- •body mass index between 18 and 40.
排除标准
- •Lack of accountability
- •positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines)
- •serious suicidal risk at screening visit
- •other relevant interferences of axis 1 according to diagnostic evaluation (MINI) including residual forms of schizophrenia.
- •other relevant neurological or other medical disorders
- •pregnancy or lactation.
研究组 & 干预措施
Cannabidiol
Cannabidiol as add-on to individualized pharmacological treatment
干预措施: Cannabidiol as add-on (Drug)
Placebo
Placebo as add-on to individualized pharmacological treatment
干预措施: Placebo as add-on (Drug)
结局指标
主要结局
All-cause discontinuation
时间窗: within 12 month
次要结局
- Improvement in Psychopathology assessed by PANSS(6, 9 and 12 month)
- Improvement in Psychopathology assessed by CGI(6, 9 and 12 month)
- Improvement in Psychopathology assessed by BSI-53(6, 9 and 12 month)
- Improvement in Psychopathology assessed by FROGS(6, 9 and 12 month)
- Changes from baseline in Depression Scale(6, 9 and 12 month)
- Improvement in social and occupational functioning assessed by GAF(6, 9 and 12 month)
- Improvement in social and occupational functioning assessed by PSP(6, 9 and 12 month)
- Improvement in social and occupational functioning assessed by EMA(6, 9 and 12 month)
- Improvement in Quality of life assessed by WHOQUOL-Bref(6, 9 and 12 month)
- Improvement in Quality of life assessed by LQLP(6, 9 and 12 month)
- Changes from baseline in Neurocognition assessed by B-CATS(6, 9 and 12 month)
- Changes from baseline in Neurocognition assessed by BACS(6, 9 and 12 month)
- Changes from baseline in Neurocognition assessed by UPSA-B(6, 9 and 12 month)
- Changes from baseline in Neurocognition assessed by MASC(6, 9 and 12 month)
- Changes from baseline in Neurocognition assessed by PFA(6, 9 and 12 month)
- Treatment adherence(6, 9 and 12 month)
- Changes in Cumulative dose of concomitant or rescue medication(6, 9 and 12 month)
- Changes of Biomarker: alterations of endocannabinoids and lipdomic profiling(6, 9 and 12 month)
研究者
F. Markus Leweke
Scientific
Zentralinstitut Fuer Seelische Gesundheit