A Double Blind Placebo Controlled Study of Valaciclovir in Treatment of Psychosis in Patients With Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To find a pre- and post-valaciclovir treatment difference in hippocampal inflammation
研究概览
简要总结
This is a one-week, randomized, double blind add-on study of valaciclovir versus placebo in 24 clinical patients with Schizophrenia according to DSM IV, currently experiencing psychosis as is defined by the positive items of the Positive and Negative Syndrome Scale (PANNS) score, being five or higher on one item or four on two items of this scale. Each patient will be randomized to double blind treatment with either valaciclovir or placebo for one week.
The main objective is to find a pre- and post-valaciclovir treatment difference in hippocampal inflammation, as measured with positron emission tomography. The secondary objective is to improve cognition by the supposed anti-inflammatory effect on the hippocampus of valaciclovir. This is measured by pre- and post-treatment performance on the PANSS, the attention and memory test.
Both the treatment team and the patient will remain blinded during the course of the study. Following the active treatment phase, patients will receive treatment as clinically indicated.
详细描述
Rationale:
Schizophrenia is a chronic and disabling brain disease, with unknown aetiology. Recently, we have shown the presence of an inflammatory process in the hippocampus of schizophrenic patients during psychosis. In addition, we found evidence for the presence of herpes viruses in the temporal lobe of schizophrenic patients during psychosis. Taken together, we hypothesize that the hippocampal inflammation is caused by the presence of herpes viruses, and that this inflammation interferes with the normal involvement of the hippocampus in cognition. Anti-viral treatment, with valaciclovir, that reduces the activity herpes viruses in the hippocampus could reduce the neuroinflammation and thus improve cognition and symptoms in schizophrenia.
Objective:
The main objective is to find a pre- and post-valaciclovir treatment difference in hippocampal inflammation, as measured with positron emission tomography, in schizophrenic patients exposed to a psychotic episode. The secondary objective is to improve cognition by the supposed anti-inflammatory effect on the hippocampus of valaciclovir.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18
- •Written informed consent for participation
- •Diagnosis: schizophrenia, all subtypes (DSM-IV 295.xx)
- •Psychosis, characterised by a total score on the positive scale on the PANSS above
- •In addition, a minimal score of 4 or more on an item of the positive scale.
排除标准
- •The use of benzodiazepines. Benzodiazepines have affinity for the peripheral benzodiazepine receptor which is the target receptor for [11C]-PK11195 PET and they can thus interfere with the PET study.
- •The use of a nonsteroidal antiinflammatory drug or paracetamol in week before the PET scans and during the treatment of valaciclovir
- •The use of anticoagulants or having coagulation disorder
- •Use of somatic medication which may affect the immune system (e.g. corticoids, anti-inflammatory drugs, immune suppressive drugs)
- •Use of any investigational drug
- •Current or recent (<1 year) alcohol or substance abuse
- •Disturbed kidney function
- •Disturbed liver function
- •Current or recent (<4 weeks) infectious or inflammatory disease
- •Current systemic disease
- •Major metabolic disease (diabetes, hyper- or hypothyroidism, Cushing disease or Addison disease)
- •Somatic, organic or neurological disorder
- •Participation in a scientific research study (<1 year) involving radiation
- •Claustrophobia
- •Presence of materials in the body that can be magnetized, like:
- •A pacemaker
- •Metal fragments
- •Artificial heart valves
- •Vascular clips
- •Fixed hearing aid
- •Tattoos containing metal
- •Hair implants
- •Artificial dentures
研究组 & 干预措施
Valaciclovir
The patients in the experimental group will be treated with 4 times 2 grams valaciclovir per day for seven days.
干预措施: Valaciclovir (Drug)
Placebo
Patient receives placebo four times a day for seven days.
干预措施: Valaciclovir (Drug)
结局指标
主要结局
To find a pre- and post-valaciclovir treatment difference in hippocampal inflammation
时间窗: 8-15 days
The main objective is to find a pre- and post-valaciclovir treatment difference in hippocampal inflammation, as measured with positron emission tomography, in schizophrenic patients exposed to a psychotic episode.
次要结局
- To find pre- and post-treatment [11C]-PK11195 binding potential in other brain areas than the hippocampus.(8-15 days)
- To find a pre- and post-valaciclovir treatment difference in hippocampal inflammation(8-15 days)
- To find whether the patients hae antibodies against common viruses(8-15 days)
研究者
Hans C Klein, MD, PhD, psychiatrist
Psychiatrist
University Medical Center Groningen