A Schizophrenia Phase III study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to evaluate the efficacy of low-dose lurasidone (20 mg/day) compared to placebo in acutely psychotic subjects with schizophrenia.;Secondary Objective: The secondary objectives of this study are:<br>- to evaluate the tolerability and safety of lurasidone 20 mg/day compared to placebo,<br>-to evaluate the efficacy, tolerability and safety of subjects initially assigned to lurasidone 80 mg/day compared to placebo (assay sensitivity arm),<br>- to evaluate the efficacy of lurasidone 80 mg/day versus 160 mg/day in early non-responders and<br>- to evaluate the efficacy of lurasidone 80 mg/day and 160 mg/day in early non-responders compared to placebo.;Primary end point(s): The primary efficacy endpoint is the change from baseline in PANSS total score at Week 6 for the lurasidone 20 mg group versus the placebo group.;Timepoint(s) of evaluation of this end point: Day 4, Week 1, 2, 3, 4, 5, and 6

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The key secondary endpoint is the change from baseline to Week 6 in CGI-S score for the lurasidone 20 mg group versus the placebo group.;Timepoint(s) of evaluation of this end point: Day 4, Week 1, 2, 3, 4, 5 and 6

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