Real-world Effectiveness and Safety of Antipsychotics in Individuals at Clinical High-risk for Psychosis: Study Protocol for a Prospective Observational Study (SHARP-2)
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Conversion to psychosis
研究概览
简要总结
The current study will improve knowledge on the effectiveness and safety of the use of antipsychotics at the prodromal phase and on factors influencing the outcome, and will eventually facilitate optimisation of individualised interventions for psychosis prevention and treatment.
详细描述
Help-seeking first-visit participants will be consecutively recruited. Every participant meeting the inclusion criteria will be fully informed of the study and asked to sign the written informed consent before enrolment.
Two senior nurses that will conduct the initial screenings were employed to collect all diagnostic and medication information from medical records on every follow-up visit. The four psychiatrists are qualified and well-trained and will conduct the SIPS/SOPS interview at baseline and follow-up.
The investigators will systematically record medication information. A model will be established to correlate antipsychotics with clinical and functional outcomes and demonstrate whether antipsychotics are useful and safe for preventing CHR individuals from converting to psychosis.
Based on experience from the sampling process in the SHARP-1 project, the investigators will recruit 600 participants at CHR. Considering a dropout rate of 20%, 510 cases of CHR will be followed up. According to the sample size calculation formula in superiority clinical trials of new drugs, the sample size of 600 cases is adequate for the demonstration of the effectiveness and safety of antipsychotics in CHR subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be aged 14 to 45-year-old
- •have had at least 6-years of primary education
- •be drug-naïve
- •be understanding the survey, be willing to enrol in the study and sign the informed consent
- •Through the Structured Interview for Prodromal Syndromes/Scale of Prodromal Symptoms (SIPS/SOPS), the participants should meet the Criteria of Prodromal Syndrome. Participants should fulfil at least one of the prodromal syndrome criteria: (1) brief intermittent psychotic syndrome, (2) attenuated positive symptom syndrome, or (3) genetic risk and deterioration syndrome
排除标准
- •Through the Mini-International Neuropsychiatric Interview (MINI), Axis I mental disorders such as schizophrenia, affective disorders, and anxiety spectrum disorders will be excluded
- •Acute or chronic renal failure; liver cirrhosis or active liver diseases
- •Abnormal laboratory tests results judged by the researchers to be clinically significant and considered to affect the efficacy of the test drugs or the safety of the subjects
- •Severe or unstable physical diseases, including: neurological disorders (delirium, dementia, stroke, epilepsy, migraine, etc.), congestive heart failure, angina pectoris, myocardial infarction, arrhythmia, hypertension (including untreated or uncontrolled hypertension), malignant tumours, immune compromise, and blood glucose above 12 mmol/L
- •Alcohol abuse within 30 days, or alcohol or drug dependence within 6 months before the trial
- •Pregnant or lactating women, or women in childbearing age who are positive in urine human chorionic gonadotropin test, or men and women who do not take effective contraceptive measures or plan for pregnancy within 3 months after the initiation of the trial
- •Stroke within the last month
- •Participating in any clinical trial within 30 days before the baseline
- •Other situations judged by the investigators not to be suitable for the clinical trial
结局指标
主要结局
Conversion to psychosis
时间窗: 4 weeks
It will be determined using the criteria for the Presence of Psychotic Symptoms from SIPS. Specifically, the conversion will be defined by the presence of level 6 positive symptoms (the rating "6" refers to severe and psychotic symptoms) identified as either dangerous, disorganised, or occurring at least one hour a day on average, over four days a week for at least 16 hours.
Poor function
时间窗: 4 weeks
It will be determined by GAF score. Specifically, poor function outcome is defined as the GAF score of less than 60 at the follow-up point.
次要结局
未报告次要终点
研究者
Tianhong ZHANG
associate research fellow
Shanghai Mental Health Center