A 12-week, Parallel, Double-blind, Randomised, Placebo-controlled Adjunctive Study of Taurine 4 Grams in 128 Patients With First-episode Psychosis Receiving Antipsychotic Treatment.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Symptomatology at 3 months
研究概览
简要总结
The purpose of this study is to determine whether Taurine 4g is effective with antipsychotic medication in the treatment of First Episode Psychosis.Taurine may have an effect on cognition and symptoms. We are examining changes in symptoms and cognition over a 3 month period.
详细描述
The core rationale of this study will be to prospectively investigate whether Taurine will improve and /or protect cognitive functioning and improve symptomatology in a cohort of 128 first episode psychosis patients.This is a randomized, double blind placebo controlled add on standard therapy trial of Taurine 4g , in young patients between 18-25 presenting to ORYGEN Youth Health a sub program of Melbourne Health and RAPPS, a subprogram of Southern Health with a first psychotic episode . Taurine will be compared with placebo added to standard treatment for a period of 12 weeks in a double blind fashion.Primary outcome measures will be psychopathology and cognition (MATRICS.
Secondary outcome measures will be tolerability and safety measures (drop-out rates, general side effect scale (UKU).
Patients who give informed consent will be randomised to receive treatment with Taurine 4g daily or placebo for 12 weeks.
Patients will be randomised by a dynamic randomisation method called minimization which allocates patients to treatment group by checking the allocation of similar patients already randomised, and allocating the next treatment group "live" to best balance the treatment groups across all stratification variables. The minimization will be carried out by the NHMRC clinical trials centre in Sydney , and the patient will be randomized to either placebo or vitamin.
Each patient will collect their tablets from the clinical trials pharmacy. The Clinical Trials Pharmacy will dispense either vitamin or placebo. All study personnel and participants will be blinded to treatment assignment for the duration of the study.
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 25 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females
- •Between 18 and 25 years of age
- •First Episode Psychosis
- •Attending ORYGEN Youth Health, a geographical based catchment area service for young people aged between 15 and 25.
排除标准
- •Organic disorders presenting with a psychotic syndrome (e.g. brain tumour, temporal lobe epilepsy, HIV encephalopathy)
- •Mental retardation (unable and/or unlikely to give appropriate information of symptomatology or side-effects (IQ approximately lower than 80)
- •History of clinically significant physical illness (e.g. terminal cancer, renal dialysis)
- •History of brain surgery
- •History of brain infarction
- •Pregnant or lactating women or women of childbearing potential not using an acceptable method of contraception.
研究组 & 干预措施
Placebo pill
4 placebo pills daily for 3 months
干预措施: Taurine 4g (Drug)
Taurine 4g
Taurine 4g daily comprising four 1g pills
干预措施: Taurine 4g (Drug)
结局指标
主要结局
Symptomatology at 3 months
Cognition (MATRICS Composite score) at 3 months
次要结局
- Safety at 3 months
- Tolerability at 3 months
