ACTRN12616000098437已完成未知
A sequential multistage randomized clinical trial (SMART) to produce evidence to guide a step-wise clinical approach for the treatment of ultra high risk patients and reduction of risk for psychosis and other deleterious clinical and/or functional outcomes.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 342
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 12 Years 至 25 Years（—）
- 性别
- All
入选标准
- •1.Age 12 -25 years (inclusive) at entry
- •2.Ability to speak adequate English (for assessment purposes)
- •3.Ability to provide informed consent. Where participants are minors (i.e. have not reached the age of eighteen), consent will also be obtained from one of the participant’s parents or legal guardian. Both the parent/legal guardian and participant will be required to sign a consent form in such a case. It will be the investigator’s responsibility to determine whether a participant who is a mature minor has the capacity and competence to consent to the study.
- •4.Meeting one or more UHR for psychosis groups:
- •Vulnerability (Trait and State Risk Factor) Group: Individuals with a combination of a trait risk factor (schizotypal personality disorder or a family history of psychotic disorder in a first degree relative) and a significant deterioration in mental state and/or functioning or sustained low functioning during the past year.
- •Attenuated Psychotic Symptoms (APS) Group: Individuals with subthreshold (intensity or frequency) positive psychotic symptoms. The symptoms must have been present during the past year and be associated with a significant reduction in or sustained low functioning.
- •Brief Limited Intermittent Psychotic Symptoms Group (BLIPS): Individuals with a recent history of frank psychotic symptoms that resolved spontaneously (without antipsychotic medication) within one week. The symptoms must have been present during the past year and be associated with a significant reduction in or sustained low functioning.
排除标准
- •1. Past history of a psychotic episode of one week or longer, whether treated with antipsychotic medications or not.
- •2. Attenuated psychotic symptoms only present during acute intoxication.
- •3. Organic brain disease known to cause psychotic symptoms, e.g. temporal lobe epilepsy.
- •4. Any metabolic, endocrine or other physical illness, e.g. thyroid disease, with known neuropsychiatric consequences.
- •5. Diagnosis of a serious developmental disorder, e.g. Severe Autism Spectrum Disorder.
- •6. Premorbid IQ<70 and a documented history of developmental delay or intellectual disability.
- •7. Previous or current SCID diagnosis of Bipolar I.
研究者
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