Enhancing recovery in early schizophrenia –a multi-center, two-arm, double-blind, randomized clinical trial investigating cannabidiol vs. placebo as an add-on to an individualized antipsychotic treatment

Zentralinstitut für Seelische Gesundheit0 个研究点目标入组 180 人开始时间: 2016年10月7日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Informed consent given by the subject
•DSM-IV-TR diagnosis of schizophrenic psychosis (295.10, 295.20, 295.30, 295.90)
•First documented diagnosis of schizophrenia must not be no older than seven years
•Patients must receive a stable dose of amisulpride (50 to 1200 mg/day), aripiprazole (10 to 30 mg/day), olanzapine (5 to 20 mg/day), quetiapine (300 to 750 mg/day), or risperidone (1 to 10 mg/day) (TAU: treatment as usual) at least four weeks prior to inclusion in the study to ensure that the maximal effect of the previous medication has been received.
•Age 18 to 65 years, male or female.
•Initial PANSS total 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.

•Lack of accountability (assessed by an independent psychiatrist)
•Positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines).
•Serious suicidal risk at screening visit (Subject to investigator’s judgement).
•Other relevant interferences of axis 1 (e.g. serious depression) according to diagnostic evaluation (MINI) including residual forms of schizophrenia.
•Other relevant neurological or other medical disorders.
•Pregnancy, determined through a ß-HCG pregnancy test, or lactation

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