CTRI/2012/08/002944已完成2 期
Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Assess the Safety and Efficacy of RP5063 in Subjects with an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder - REFRESH
Reviva Pharmaceuticals Inc0 个研究点目标入组 228 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 228
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subjects with a clinical diagnosis of acute exacerbation of schizophrenia or schizoaffective disorder (at least one year prior to screening) according to DSM-IV-TR criteria as aided by Mini International Neuropsychiatric Interview (M.I.N.I.) 6.0 for Schizophrenia and Psychotic Disorders Studies (Appendix VI).
- •Subjects experiencing an acute exacerbation of psychosis where the following criteria are met:
- •oScreening score on the BPRS of >36 and BPRS psychosis cluster a minimum score of 4 or higher on at least two of the four items: suspiciousness, conceptual disorganization, hallucinatory behavior, and/or unusual thought content
- •oCurrent exacerbating episode has lasted no longer than 4 weeks
排除标准
- •Female subjects who are pregnant or lactating
- •Subjects presenting concurrent dementia, delirium, mental retardation, epilepsy/seizure,drug-induced psychosis, mood disorders, including bipolar mania and major depression
- •Presence or history within the previous 3 months of significant and/or uncontrolled hematological, renal, hepatic, endocrinological, neurological or cardiovascular disease
- •Clinically significant abnormalities as per Investigatorâ??s discretion
- •History of neuroleptic malignant syndrome induced by any antipsychotic medication in the past
- •Subjects with a history of Human Immunodeficiency Virus (HIV) infection but no HIV or Hepatitis testing will be done
- •Subjects who meet DSM-IV criteria for alcohol or any substance dependence disorder within 3 months prior to screening
- •A positive qualitative urine drug test by dipstick method at screening or evidence of either any withdrawal from or acute intoxication such as alcohol, cocaine, opiates, (meth) amphetamines, marijuana and barbiturates
- •Subjects with history of electroconvulsive therapy (ECT) within the past 3 months of screening or who may require ECT during the study.
研究者
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