Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Scale for the Assessment of Negative Symptoms (SANS) score
研究概览
简要总结
The purpose of the study is to investigate whether blockade of the histamine H2 receptors in the brain will have any beneficial effect on the symptoms of subjects with schizophrenia.
详细描述
Histamine functions as a neurotransmitter in the brain. It has an important role as modulator of the release of other neurotransmitters, including dopamine.
The histamine receptors are widely expressed in the brain, H1 and H2 receptors are post-synaptic, H3 a pre-synaptic autoreceptor. There is an abundance of neurobiologic data from animal and human studies supporting the role of histamine in the pathogenesis and treatment of psychoses.
In 1990 a case report of a treatment resistant subject with schizophrenia whos symptoms improved markedly when he was prescribed a H2 antagonist because of peptic ulcer. Later, a open-label trial including 18 patients has been performed, reporting significant symptom reduction, especially on negative symptoms. Also the subjective comments both by the subjects and the investigators in that study were optimistic and suggested an effect primarily on negative symptoms.
The present study will be the first double-blind, randomized, placebo controlled, parallel group study of the subject matter. The study focuses on treatment resistant schizophrenia cases in the stable phase.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of schizophrenia assessed by SCID-I (DSM-IV) as well as RDC-criteria
- •Patient record mention of schizophrenia (ICD-10) at least 5 years previously
- •Disability pension due to psychiatric disorder
- •At least 3 points on the CGI scale
排除标准
- •Epilepsy or a history of unclear seizures
- •Parkinson's disease
- •Substance addiction or abuse within 3 months prior to enrolment.
- •Individuals who are deemed at risk for aggressive behavior or suicide by their clinician
- •Pregnant and breast-feeding subjects
- •Serious unstable physical illness
- •Persons who have been deemed legally incapacitated according to Finnish law (Laki holhoustoimesta 1.4.1999/442,
- •luku, 18 §)
- •Individuals who use H2-antagonists as prescribed by a physician
- •Known allergy to famotidine or any other component of the Pepcidin® 40 mg tablet
- •Glomerular Filtration Rate (GFR) according to the Cockcroft-Gault formula < 30 ml/min
研究组 & 干预措施
famotidine
干预措施: famotidine (Drug)
Placebo
干预措施: Placebo (Microcrystallized cellulose) (Drug)
结局指标
主要结局
Scale for the Assessment of Negative Symptoms (SANS) score
时间窗: 5 weeks
次要结局
- Positive and Negative Syndrome Scale (PANSS) score(5 weeks)
- Clinical Global Impression (CGI) score(5 weeks)
研究者
Jesper Ekelund
Professor of psychiatry
University of Helsinki