A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LOW-DOSE LURASIDONE IN ACUTELY PSYCHOTIC SUBJECTS WITH SCHIZOPHRENIA

Sunovion Pharmaceuticals Inc0 个研究点目标入组 400 人开始时间: 2013年3月8日最近更新: 2014年11月3日

适应症

试验速览

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•Subject is = 18 and = 75 years of age, and meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia [including disorganized (295.10), paranoid (295.30), undifferentiated (295.90) subtypes] as established by clinical interview (using the DSM-IV-TR as a reference and confirmed by the SCID-CT). The duration of the subject’s illness whether treated or untreated must be = 6 months. Subject has a PANSS total score = 80 and PANSS subscale score = 4 (moderate) on 2 or more of the following PANSS subscale items: delusions, conceptual disorganization, hallucinations, and unusual thought content at screening and baseline and a CGI-S score of = 4 at screening and baseline. Subject has an acute exacerbation of psychotic symptoms (no longer than 2 months) and marked deterioration of function from baseline (by history) or subject has been hospitalized for the purpose of treating an acute psychotic exacerbation for 2 consecutive weeks or less immediately before screening.
•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 380
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Diagnosis of a DSM-IV Axis I or Axis II diagnosis, other than schizophrenia, that has been the primary focus of treatment within 3 months of screening. Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.

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