EUCTR2013-000415-25-RO进行中（未招募）1 期
A randomized, double-blind, placebo controlled study to evaluate the efficacy and safety of Naproxen, Simvastatin and their combination, compared to placebo as add-on to anti-psychotics in the treatment of patients with schizophrenia and schizoaffective disorder. - NAS-S-01
Clinirx Tangent Research0 个研究点目标入组 232 人开始时间: 2020年2月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 232
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female, 18-65 years of age, inclusive
- •2.Females who are abstinent or practicing an established method of birth control (oral contraceptive tablets, hormonal implant device, hormone patch, injectable contraceptive, intrauterine device [IUD]).
- •3.Willing and able to provide informed consent, after the nature of the study has been fully explained
- •4.Current DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder as confirmed by modified SCID and having had at least 2 prior schizophrenic episodes, or continually ill for at least 6 months.
- •5.Symptoms: 4 (moderate) or above on CGI-S and ? 4 (moderate) score on two of the following four PANSS items: delusions, hallucinatory behaviors, conceptual disorganization or suspiciousness/ persecution, and/or a total PANSS negative symptoms score of 18.
- •6.Must be on any antipsychotic drug, for at least 2 weeks prior to the baseline visit, at doses within the PORT criteria, whenever possible. Patients receiving higher doses will have their records reviewed to insure that their dose is required and, if possible, will be stabilized on a lower dose prior to study entry.
- •7.Inpatients or outpatients. Inpatients will be randomized 3 days or more after admission
- •8.Onset of illness, defined as the first admission for psychosis, was 10 years or less before recruitment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 232
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Unwilling or unable, in the opinion of the Investigator, to comply with study instructions
- •2.Pregnant or breast-feeding
- •3.Unstable medical disease (malignancy, cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning, history of hemorrhagic CVA or peptic ulcer disease.
- •4.Patients suffering from diabetes or ischemic cardiac disease
- •5.Patients treated with: any of the trial medications i.e. NSAIDs, anti-coagulants or statins on a daily basis.
- •6.Likely allergy or sensitivity to trial medications
- •7.At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.
- •8.Patients with a current DSM-IV substance or alcohol abuse. Patients with a history of and/or current recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included
- •9.Concurrent delirium, mental retardation, drug-induced psychosis, or history of clinically significant brain trauma documented by CT or MRI.
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