A randomized trial administering aspirin vs. placebo as add-on to antipsychotics in patients with schizophrenia or schizoaffective disorder with high CRP levels - ASA-CRP-01

Clinirx Tangent Research0 个研究点目标入组 160 人开始时间: 2014年5月30日最近更新: 2016年6月20日

适应症

试验速览

暂无简介。

•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.CRP = 1mg/L
•6.Symptoms: 4 (moderate) or above on CGI-S and ? 4 (moderate) score on two of the following four PANSS positive items: delusions, hallucinatory behaviors, conceptual disorganization or suspiciousness/ persecution.
•7.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.
•8.Inpatients or outpatients. Inpatients will be randomized 3 days or more after admission
•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 160
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning, history of hemorrhagic CVA or peptic ulcer disease).
•4.Patients treated with acetylsalicylic acid, NSAIDs, anti-coagulants.
•5.Likely allergy or sensitivity to acetylsalicylic acid.
•6.At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.
•7.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.
•8.Concurrent delirium, mental retardation, drug-induced psychosis, or history of clinically significant brain trauma documented by CT or MRI.

发起方

Clinirx Tangent Research