The effect of Cannabidiol on positive psychotic symptoms in At Risk for psychosis Youth: A randomised controlled trial

Orygen0 个研究点目标入组 405 人开始时间: 2021年3月26日最近更新: 2024年5月27日

适应症

试验速览

暂无简介。

•1.Aged 12-25 years (inclusive) at entry;
•2.Sufficient fluency in English (for assessment purposes);
•3.Ability to provide informed consent (parental/guardian consent will be obtained for participants aged <18 years);
•4.Meeting one or more UHR for psychosis groups as defined in Table 1 of the study protocol; and
•5.Attenuated psychotic symptoms present in the past month at UHR level as defined in Table 1 of the study protool.

•1.Ultra-High Risk symptoms only present during acute intoxication
•2.If prescribed psychotropic medication (e.g. antidepressant medication) the individual must have been on a stable dose for a minimum of 6 weeks prior to randomisation). Antipsychotic medication is not an exclusion criterion. In the case of current antipsychotic use, medication will be tapered and ceased at entry to the study.
•3.Pregnancy, lactation, or if sexually active, no effective contraception (applies to both male and female participants)
•4.Clinical blood test findings that might compromise participant safety or confound the trial results
•5.Acute or unstable systemic medical disorder
•6.Psychiatric condition due to a medical condition;
•7.Severe disturbance, such that the person is unable to comply with either the requirements of informed consent or the treatment protocol
•8.Current acute suicidality/self- harm or aggression/dangerous behaviour
•7. Diagnosis of a serious developmental disorder or a documented history of developmental delay or intellectual disability
•9.History of a psychotic episode of one week or longer

发起方

Orygen