Enhancing the Prospective Prediction of Psychosis
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Meets modified criteria of prodromal syndromes (COPS) for schizophrenia prodrome or help-seeking control
Exclusion Criteria:
- History of psychosis
- Antipsychotic treatment in the month prior to study entry
- More than 16 weeks of lifetime antipsychotic treatment
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
---|
1
Participants with basic symptoms of psychosis
|
2
Control participants
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Information on the natural history of basic symptoms of psychosis
大体时间:Measured monthly during Year 1; every 2 months during Year 2; and every 3 months during Years 3, 4, and 5
|
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
大体时间:Measured monthly during Year 1; every 2 months during Year 2; and every 3 months during Years 3, 4, and 5
|
Measured monthly during Year 1; every 2 months during Year 2; and every 3 months during Years 3, 4, and 5
|
合作者和调查者
调查人员
- 首席研究员:Scott W. Woods, MD、Yale School of Medicine
- 首席研究员:Jean Addington, PhD、University of Toronto
- 首席研究员:Diana O. Perkins, MD, MPH、University of North Carolina
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- MH61282
- 5U01MH066160 (美国 NIH 拨款/合同)
- DATR AD-P
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