NCT01754532已完成不适用
Correlation Between Clinical Deterioration in Schizophrenic Patients and Hair Cortisol Levels
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change from Baseline in Positive And Negative Symptoms Score
研究概览
简要总结
The importance of stress as a possible deteriorating factor for schizophrenic patients is well documented. However, this notion is based on subjective experience and retrospective psychological analysis.
A novel method of measuring cortisol using hair has a proven correlation to subjective stress in non-clinical as well as psychiatric clinical populations.
This pilot study will attempt to assess the use of cortisol hair level, as a marker of stress, to predict clinical deterioration in schizophrenic patients.
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-50
- •Diagnosis of schizophrenia or schizoaffective disorder, made by a senior psychiatrist.
- •Signing an informed consent.
排除标准
- •Additional psychiatric diagnosis
- •Boldness or hair shorter than 1cm
- •Physiological disturbance in the HPA or the use of steroidal medication
- •Neurological disease (past or present) or neurosurgery.
- •Pregnancy
- •Substantial chronic physical diseases/
结局指标
主要结局
Change from Baseline in Positive And Negative Symptoms Score
时间窗: 6 month
correlation between hair cortisol level change from baseline and PANSS score change from baseline.
次要结局
- Change from Baseline in SANS, CGI, CDS, GAF and QOL Scores(6 month)
研究者
Aviv Segev
Resident
Shalvata Mental Health Center
研究点 (1)
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