A randomized trial administering Sodium Nitroprusside vs. placebo as add-on to antipsychotics in patients with schizophrenia - ASA-CRP-01

Clinirx Tangent Research0 个研究点目标入组 20 人开始时间: 2015年3月5日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•1.Males and females between 19 to 40 years of age.
•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 diagnosis of schizophrenia as confirmed by modified SCID.
•5.First diagnosed with schizophrenia no more than 5 years before the trial
•6.Total PANSS score at baseline = 60.
•7.Patients in an acute psychotic episode requiring full-time hospitalization according to clinical referral by the relevant mental health service.
•8.During the life time must have been on an antipsychotic drug for at least 6 months
•9.No change in psychotropic medication over the last 1week before baseline.
•10.Female participants willing to have a pregnancy test before treatment.
•11.Willing to remain under observation for the entire 4 weeks trial period
•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 20
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Unstable medical disease, such as malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning.
•2.Prior history of intolerance to Sodium Nitroprusside.
•3.Presence of a seizure disorder, not including clozapine-induced seizures.
•4.Currently taking clozapine and/or antihypertensive medication.
•5.At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.
•6.Diagnosis of substance abuse (except nicotine or caffeine) or dependence within the last 3 months according to DSM-IV criteria.
•7.Clinically significant use of illicit substances or alcohol in the past 3 months.
•8.Pregnant or breastfeeding.

发起方

Clinirx Tangent Research