跳至主要内容
临床试验/CTRI/2012/03/002509
CTRI/2012/03/002509招募中3 期

A randomized, double-blind, placebo-controlled, parallel-group study of Cariprazine (RGH-188) in the prevention of relapse in patients with schizophrenia

Forest Research Institute Inc0 个研究点目标入组 900 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
招募中
入组人数
900

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

  • Patients who have provided informed consent prior to any study specific procedures
  • Current diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria as determined by the Structured Clinical Interview for DSM-IV (SCID)
  • Patients with normal physical examination, laboratory, vital signs, and/ or ECG
  • Diagnosis of schizophrenia for a minimum of 1 year before Visit 1
  • PANSS total score greater than or equal to 70 and less than or equal to 120 at Visit 1 and Visit 2
  • Negative serum B-human chorionic Gonadotropin (B-hCG) pregnancy test (applies to female patients of childbearing potential only)
  • Body mass index between 18 and 40kg/m2, inclusive

排除标准

  • Patients currently meeting DSM-IV-TR criteria for schizoaffective disorder, schizophreniform disorder, bipolar I and II and known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorders
  • Patients in their first episode of Psychosis
  • Treatment-resistant schizophrenia over the last 2 years
  • Positive result from the blood alcohol test or from the urine drug screen for any prohibited medication
  • At imminent risk of injuring self or others or causing significant damage to property
  • Suicide risk

研究者

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