Schizophrenia MedDRA version: 15.1 Level: LLT Classification code 10001064 Term: Acute schizophrenia System Organ Class: 100000004873
Conditions
Sponsors
Sunovion Pharmaceuticals Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: - to evaluate the tolerability and safety of lurasidone 20 mg/day compared to placebo, -to evaluate the efficacy, tolerability and safety of subjects initially assigned to lurasidone 80 mg/day compared to placebo (assay sensitivity arm), - to evaluate the efficacy of lurasidone 80 mg/day versus 160 mg/day in early non-responders and - 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Colombia, Romania, Russian Federation, Serbia, Slovakia, Ukraine, United States
Contacts
Public ContactJosephine Cucchiaro
Sunovion Pharmaceuticals Inc
Outcome results
None listed