The Topical Niacin Skin Flush Test: A Means for Longitudinal Monitoring of Two Different Biological Subgroups of Patients With First Episode Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- change in visual rating of skin response (redness and oedema)
研究概览
简要总结
The purpose of this study is to gather normative data from healthy adults and to determine a sensitive and specific cut-off value for responders and non-responders to the Niacin Skin Flush Test in a sample of first episode psychosis 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
- 19 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •caucasian
- •within twelve months of initial DSM IV TR diagnosis of schizophreniform psychosis, schizophrenia, schizoaffective disorder or psychotic disorder NOS
- •outpatient
排除标准
- •known allergy to study compound (methyl nicotinate, vitamin B3, niacin)
- •skin conditions (e.g., dermatitis, psoriasis, eczema)
- •diagnosis or treatment for medical conditions that may affect normal vascular tone (e.g., diabetes, vasculitis, chronic hypertension, etc.)
- •Use of anti-inflammatory, antibiotic, or antihistamine medications within one month prior to study entry
- •Use of supplements like Omega 3 fatty acids within 3 months prior to study entry
- •Use of vitamin or nutritional supplement containing a dose of niacin/nicotinic acid above 50 mg/day at study entry
结局指标
主要结局
change in visual rating of skin response (redness and oedema)
时间窗: ratings made at 3, 6, 9 and 12 minutes after application of methyl nicotinate
A 7-point visual rating scale, previously tested for reliability (Kerr 2008), to visually rate the skin response to aqueous methyl nicotinate (niacin) with respect to both redness and oedema as a function of increasing niacin concentrations.Ratings will be acquired every three minutes over a 12-minute period starting at the time of solution application.
次要结局
未报告次要终点
研究者
Beverly Butler
Research Neuropsychologist
Nova Scotia Health Authority