A Multicentre 12-week Randomised Double-blind Placebo Controlled Feasibility Trial of Sodium Benzoate and/or N-acetylcysteine Added to TAU in Patients With Early Schizophrenia Spectrum Disorder.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 5
- 主要终点
- Feasibility of intervention ( including recruitment rates and drop outs)
研究概览
简要总结
This study aims to determine if the addition of Sodium Benzoate and / or NAC to TAU will be acceptable and tolerable and result in overall improvement of symptoms, social and cognitive functioning in patients with early schizophrenia spectrum disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind placebo controlled trial
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/Female patients aged between 18-35 years.
- •Diagnosis of schizophrenia confirmed by SCID interview meeting DSM-V criteria for schizophrenia, schizophreniform or schizoaffective psychosis.
- •Stable on medication for the past four weeks
- •In contact with mental health services
- •Within 5 years of diagnosis of psychotic illness
- •Able to demonstrate the capacity to provide informed consent as assessed by their own clinician
- •Able to complete the required evaluations and take oral medication.
- •Effective contraceptive precautions (either the use of barrier methods or the oral contraceptive pill) to be taken by women of child-bearing age. A negative pregnancy test will be required in order to meet inclusion criteria.
排除标准
- •Prior history of intolerance or serious side effects to Sodium Benzoate or N-acetylcystine.
- •Concomitant use of Ascorbic acid
- •Active substance abuse (except nicotine or caffeine) or dependence within the last three months according to DSM-V criteria.
- •Relevant CNS or other medical disorders.
- •Pregnant or breast feeding
- •Diagnosis of Moderate to Severe Learning Disability
- •Relevant current or past haematological, hepatic, renal, neurological or other medical disorder in the opinion of the principal investigator (PI) or the responsible clinician, that may interfere with the trial.
研究组 & 干预措施
Sodium Benzoate
Sodium Benzoate added to TAU will be administered at 1000mg daily
干预措施: Sodium Benzoate (Drug)
N-Acetylcysteine
N-Acetylcysteine added to TAU 1000 mgs twice daily dose
干预措施: N-Acetylcysteine (Drug)
Placebo
Placebo added to TAU
干预措施: Placebo (Drug)
Sodium Benzoate Plus N-Acetylcysteine
Sodium Benzoate will be administered at 1000mg daily and NAC 1000 mgs twice daily dose
干预措施: Sodium Benzoate Plus N-Acetylcysteine (Drug)
结局指标
主要结局
Feasibility of intervention ( including recruitment rates and drop outs)
时间窗: Recruitment within 12 months of study start start date
Feasibility estimates of delivering the intervention including recruitment rates and drop outs
次要结局
- Overall improvement in symptoms using the Positive and Negative Syndrome Scale (PANSS) total score(change in scores from Baseline to 12 weeks)