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Enhancing the Prospective Prediction of Psychosis

2014年6月9日 更新者:Yale University
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.

研究概览

地位

完全的

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

观察性的

注册 (实际的)

268

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ontario
      • Toronto、Ontario、加拿大
        • PRIME Clinic
    • Connecticut
      • New Haven、Connecticut、美国、06519
        • Prevention through Risk Identification Management and Education (PRIME) Clinic
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599
        • PRIME Clinic

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 至 35年 (孩子、成人)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

The study population consists of participants who meet the basic symptoms for psychosis and control participants recruited at three sites: the PRIME Clinics at University of North Carolina, Yale University, and the Center for Addiction and Mental Health (CAMH) in Toronto, Canada.

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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

在这里您可以找到参与这项研究的人员和组织。

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

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2003年8月1日

初级完成 (实际的)

2009年2月1日

研究完成 (实际的)

2009年2月1日

研究注册日期

首次提交

2006年2月10日

首先提交符合 QC 标准的

2006年2月10日

首次发布 (估计)

2006年2月13日

研究记录更新

最后更新发布 (估计)

2014年6月10日

上次提交的符合 QC 标准的更新

2014年6月9日

最后验证

2014年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • MH61282
  • 5U01MH066160 (美国 NIH 拨款/合同)
  • DATR AD-P

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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