V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
研究概览
简要总结
This is an 18 week (2 weeks run-in, 16 weeks double blind) trial, to determine if an antiviral drug, valacyclovir (Valtrex) is helpful in treating the symptoms of psychosis, a form of a mental disorder.
详细描述
There is evidence that some of the symptoms of psychosis may be related to past infection with common viruses.
Researchers are looking to recruit a total of 100 subjects with evidence in the past, of exposure to at least 1 of 3 viruses. The viruses include herpes type 1 (HSV-1, which causes cold sores of the lip and has affected about 6/10 people in Vancouver), herpes type 2 (HSV-2 which causes genital sores, and has affected less than 1/10 people in Vancouver) and cytomegalovirus (CMV, which causes few symptoms but has affected 8/10 people in Vancouver). People who have been infected with these viruses in the past develop antibodies in the blood. The antibodies can be measured in blood, and are a test of whether or not there was infection in the past, and possibly affecting the symptoms of psychosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects antipsychotic, mood stabilizing and antidepressant drug treatment must have been stable for at least 3 months, and there is no plan to change the drug treatment during the 4-month phase of the study.
- •Subjects must be seropositive for HSV-1, HSV-2 and/or CMV.
- •Subjects must achieve a level of understanding and expressive capacity sufficient to communicate adequately with the study coordinator and to participate in cognitive testing.
- •Subjects must be able to provide written informed consent.
排除标准
- •Females of childbearing age will agree not to become pregnant and will agree to use a medically acceptable method of birth control.
- •Inability to participate in cognitive testing due to severe persistent psychosis or other condition.
- •Mental handicap.
- •Subjects with known hypersensitivity or allergy to valacyclovir or acyclovir.
- •Patient taking nontopical antiviral medications with anti-herpes activity on a regular basis