A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia

• Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  The PANSS is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.
• Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
• Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.

A 6-week in-patient and out-patient study to test the effectiveness and safety of a new medication in the treatment of schizophrenia

Study will evaluate the efficacy of a new compound versus placebo in the treatment of patients with schizophrenia (diagnosed by DSM-IV criteria) as measured by reductions from baseline on the total score of the Brief Psychiatric Rating Scale (BPRS) as extracted from the Positive and Negative Syndrome Scale (PANSS).

• Drug: Lurasidone
  80 mg AM dosing once daily
• Drug: Lurasidone
• Drug: Placebo
  Matching Placebo to 40mg lurasidone tablets

• Experimental: Lurasidone
  80 mg AM dosing once daily
  Intervention: Drug: Lurasidone
• Placebo Comparator: Placebo
  Interventions:

  • Drug: Lurasidone
  • Drug: Placebo

Inclusion Criteria:

• Satisfy DSM-IV criteria for schizophrenia as established by SCID-CV
• The patient must agree to a voluntary hospitalization duration of 31 days minimum at the start of the treatment
• If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception

Exclusion Criteria:

• The patient has used an investigational drug within the past 30 days
• The patient has participated in a previous study of this compound