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临床试验/NCT00291200
NCT00291200已完成不适用

Enhancing the Prospective Prediction of Psychosis

Yale University2 个研究点 分布在 2 个国家目标入组 268 人开始时间: 2003年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
268
试验地点
2
主要终点
Information on the natural history of basic symptoms of psychosis

研究概览

简要总结

This study will gather information on the natural history of the basic symptoms of psychosis to identify factors that may affect the improvement or persistence of the symptoms.

详细描述

Psychosis is a serious mental condition in which a person momentarily loses contact with reality. People in a state of psychosis may experience hallucinations or delusional beliefs that make day-to-day functioning difficult. During the early development of psychosis, people undergo an initial change in mood, thinking, or behavior that may include making mistakes about smells, sounds, or sights; becoming easily distracted; and developing suspicions of others. These basic symptoms can be early warning signs of a brain disorder, including anxiety disorder, depression, or psychotic disorder. Basic symptoms may be due to a number of factors, including a reaction to stress or drugs or just a part of normal adolescence. To identify psychosis early and accurately, more information is needed on the initial stages, biological markers, and progression of psychosis. This study will gather information on the natural history of the basic symptoms of psychosis to identify factors that may affect the improvement or persistence of the symptoms.

Participation in this study will last up to 5 years. The initial screening visit will be used to determine whether a participant is eligible for the group displaying basic symptoms or the control group. Initial screening will include giving a blood sample for routine lab tests, a physical exam, a drug test, and questions about medical history and symptoms. All participants will then partake in baseline evaluations, which involve assessments concerning concentration, problem solving, memory, social skills, and ability to identify smells. Participants will also respond to questions about symptoms, school and social functioning, stressful situations, and family history of illnesses. The participants who meet the criteria for basic symptoms will attend monthly 1-hour follow-up visits for the first year of the study. During these visits, participants will be asked about the status of their basic symptoms and use of medications. For the second year of the study, follow-up visits will occur every 2 months, and for the third, fourth, and fifth years of the study, visits will be every 3 months. Repeat baseline assessments will occur every 6 months, with each assessment visit lasting about 5 hours. All participants will undergo endpoint evaluations that follow the same format as most baseline assessments. Participants who develop a psychotic disorder during the study will attend an additional follow-up visit 6 months after the endpoint evaluation to confirm diagnosis. Participants who decide that they no longer wish to attend regular study visits may be asked to participate in follow-up telephone interviews about their basic symptoms every 6 months.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
12 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Meets modified criteria of prodromal syndromes (COPS) for schizophrenia prodrome or help-seeking control

排除标准

  • History of psychosis
  • Antipsychotic treatment in the month prior to study entry
  • More than 16 weeks of lifetime antipsychotic treatment

结局指标

主要结局

Information on the natural history of basic symptoms of psychosis

时间窗: Measured monthly during Year 1; every 2 months during Year 2; and every 3 months during Years 3, 4, and 5

Factors that may affect the improvement or persistence of basic symptoms of psychosis

时间窗: Measured monthly during Year 1; every 2 months during Year 2; and every 3 months during Years 3, 4, and 5

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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