NCT01946295Unknown2 期
Histamine H2 Antagonism as Adjuvant Therapy in Treatment Resistant Schizophrenia
Jesper Ekelund6 个研究点 分布在 2 个国家目标入组 140 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 140
- 试验地点
- 6
- 主要终点
- Change from Baseline in Positive and Negative Syndrome Scale (PANSS) at 8 weeks
研究概览
简要总结
Objective of the trial is to study if famotidine add-on treatment is more effective than placebo add-on in reducing symptoms of schizophrenia among patients receiving insufficient response to ongoing antipsychotic treatment.
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
- •ICD-10 diagnosis of schizophrenia (F20.00-20.39, F20.5, F20.9) who have had the disorder for at least 5 years and who are on disability pension. (This means that their treatment response is not satisfactory and for the purpose of this study, the subjects are potentially treatment resistant).
- •Clinical Global Impression (CGI) severity score of at least
- •No changes in schizophrenia treatment within 12 weeks before study inclusion.
- •Written informed consent
- •The subjects must fulfil schizophrenia criteria both according to DSM- IV (295.10, .20, .30, .60, .90) (American Psychiatric association) and the Research Diagnostic Criteria for schizophrenia (RDC) [40]. They must also have at least mild residual symptoms (CGI 3 points). The DSM-IV diagnosis will be verified by use of the SCID-I [41]. The DSM-IV is clearly the most commonly used in psychiatric research, so this is important to be able to generalize the findings. However, several previous studies have used the RDC, so to be able to compare the results, we will diagnose the patients according to both systems.
- •Women of child-bearing age will be included only of they use adequate contraception, or if we can otherwise verify that the subject is not pregnant (s-HCG), the possibility of pregnancy is negligible (e.g. the personnel of the housing facility reports that the person has not had sexual relationships for years) and the subject approves to remain sexually abstinent for the duration of the study.
排除标准
- •Epilepsy or a history of unclear seizures, stroke, Parkinson's disease, AIDS
- •History of substance addiction or abuse within 3 months prior to enrolment.
- •Individuals who are deemed at risk for aggressive behaviour or suicide
- •If their laboratory tests, EKG or other clinical observation warrants exclusion, they will be excluded
- •Women who are pregnant or breast-feeding subjects will not be included in the study.
- •Patients with any serious unstable physical illness will also be excluded
- •Patients who have been deemed to be legally incapacitated according to Finnish or Swedish law.
- •Regular Uuse of H2-antagonists as prescribed by a physician.
- •Known allergy to famotidine or any other component of interventional drug will be excluded.
- •Ongoing treatment with clozapine and dixyrazine.
- •Clinical condition "very much improved" or "much improved", assessed by CGI, during the placebo lead-in
- •Renal insufficiency (P-creatinine not within normal range. Glomerular filtration rate <30 ml/min according to the Cockcroft-Gault formula. )
- •Liver insufficiency (S-ALAT elevated more than 2-fold above the laboratory specific normal range)
研究组 & 干预措施
Famotidine
Experimental
Famotidine 100mg x 2 orally
干预措施: Famotidine (Drug)
Placebo
Placebo Comparator
Placebo control
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) at 8 weeks
时间窗: Rating at start of treatment (0 weeks) and at end of treatment (8 weeks)
In addition PANSS ratings are done at screening, every two weeks during treatment and two weeks after end of treatment.
次要结局
- Change from Baseline in The Overall Anxiety Severity and Impairment Scale (OASIS)at 8 weeks(Rating at start of treatment (0 weeks) and at end of treatment (8 weeks))
- Change from Baseline in Clinical Global Impression (CGI) scale at 8 weeks(Rating at start of treatment (0 weeks) and at end of treatment (8 weeks))
- Change from Baseline in Calgary Depression Scale (CDS) at 8 weeks(Rating at start of treatment (0 weeks) and at end of treatment (8 weeks))
- Change from Baseline in CogState scores at 8 weeks(Rating at start of treatment (0 weeks) and at end of treatment (8 weeks))
- Change from baseline in nightly sleep duration measured with actigraphy at 8 weeks(Measurement at start of treatment (0 weeks) and at end of treatment (8 weeks))
研究者
Jesper Ekelund
Professor
University of Helsinki
研究点 (6)
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