A Study of LY2140023 in Patients With Schizophrenia

• Change from baseline in the PANSS total score in a predefined genetic subpopulation of schizophrenia patients [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: No ]
• Change from baseline in the Personal and Social Performance (PSP) score in a predefined subpopulation [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: No ]
• Change from baseline in the PSP score [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: No ]
• Proportion of participants who are responders [ Time Frame: Baseline up to 7 weeks ] [ Designated as safety issue: No ]
• Time to response [ Time Frame: Baseline up to 7 weeks ] [ Designated as safety issue: No ]
• Change from baseline in the Clinical Global Impression-Severity (CGI-S) Scale [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: No ]
• Change from baseline in the 16-item Negative Symptoms Assessment (NSA-16) [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: No ]
• Change from baseline on EuroQOL - 5 dimension (EQ-5D) Questionnaire [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: No ]
• Change from baseline on Schizophrenia Resource Utilization Model (S-RUM) [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: No ]
• Change from baseline on Subjective Well-Being Under Neuroleptic Treatment Scale - Short Form (SWN-S) [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: No ]
• Change from baseline in Barnes Akathisia Scale (BAS) [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: Yes ]
• Change from baseline in Simpson-Angus Scale (SAS) [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: Yes ]
• Change from baseline in Abnormal Involuntary Movement Scales (AIMS) [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: Yes ]
• Number of participants with suicidal behaviors and ideations measured by the Columbia-Suicide Severity Rating Scale (CSSRS) [ Time Frame: Baseline up to 7 weeks ] [ Designated as safety issue: Yes ]
• Rate of discontinuation [ Time Frame: Baseline up to 7 weeks ] [ Designated as safety issue: No ]
• Time to discontinuation [ Time Frame: Baseline up to 7 weeks ] [ Designated as safety issue: No ]
• Change from baseline in the PANSS subscores [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: No ]
• Change from baseline in Prolactin [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: Yes ]
• Change from baseline in weight [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: Yes ]
• Change from baseline in the PANSS total score in females [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: No ]

The purpose of this study is to determine whether at least 1 dose level of LY2140023 given to acutely ill patients with schizophrenia will demonstrate significantly greater efficacy as compared to placebo.

• Drug: LY2140023
  Administered orally
• Drug: Placebo
  Administered orally

• Experimental: 80 mg LY2140023
  40 mg LY2140023 administered orally, twice daily (BID) for up to 7 weeks of treatment.
  Intervention: Drug: LY2140023
• Experimental: 40 mg LY2140023
  20 mg LY2140023 administered orally, BID for up to 7 weeks of treatment.
  Intervention: Drug: LY2140023
• Experimental: 10 mg LY2140023
  5 mg LY2140023 administered orally, BID for up to 7 weeks of treatment.
  Intervention: Drug: LY2140023
• Placebo Comparator: Placebo
  Administered orally, BID for up to 7 weeks of treatment.
  Intervention: Drug: Placebo

Inclusion Criteria:

• Diagnosis of schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision DSM-IV-TR; and confirmed by the Structured Clinical Interview for DSM-IV-TR (SCID)
• Non pregnant female patients who agree to use acceptable birth control
• Participants must be considered moderately ill in the opinion of the investigator
• Patients in whom a modification of antipsychotic medication or initiation of antipsychotic medication is acutely indicated in the opinion of the investigator
• Willing to participate in a minimum of 2 weeks of inpatient hospitalization.
• One year history of Schizophrenia prior to entering the study
• At study entry patients with a history of antipsychotic treatment must have a lifetime history of at least one hospitalization for the treatment of schizophrenia, not including the hospitalization required for study. Patients who have never taken antipsychotic treatment may enter the study even without a history of hospitalization
• At study entry patients with a history of antipsychotic treatment must have a history of at least one episode of illness exacerbation requiring an intensification of treatment intervention or care in the last 2 years, not including the present episode of illness. Patients who have never taken antipsychotic treatment may enter the study without a past history of illness exacerbation and intensification of treatment in the last 2 years
• At study entry patients must have experienced an exacerbation of illness within the 2 weeks prior to entering the study, leading to an intensification of psychiatric care in the opinion of the investigator. If exacerbation occurs in patients who are presently hospitalized, the patient must not have been hospitalized longer than 60 days at entry of the study
• Patients must be considered reliable and have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures

Exclusion Criteria:

• Patients who have a history of inadequate clinical response to antipsychotic treatment for schizophrenia
• Diagnosis of substance dependence or substance abuse within 6 month of study entry
• Diagnosis of substance-induced psychosis within 7 days of study entry
• Currently enrolled in, or discontinued within 6 months from a clinical trial involving an investigational product or unapproved use of a drug or device
• Participated in any clinical trial with any pharmacological treatment intervention for which they received a study-related medication in the 6 months prior to study entry
• Previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity
• Treatment with clozapine at doses greater than 200 mg daily within 12 months prior to entering the study, or who have received any clozapine at all during the month before study entry
• Patients currently receiving treatment (within 1 dosing interval, minimum of 4 weeks, prior entering the study) with a depot formulation of an antipsychotic medication
• Patients who are currently suicidal
• Females who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study
• Patients with uncorrected narrow-angle glaucoma, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other serious or unstable illnesses
• Have a history of one or more seizures
• Electroconvulsive therapy (ECT) within 3 months of entering the study or who will have ECT at any time during the study
• History of low white blood cell count
• Medical history of Human Immunodeficiency Virus positive (HIV+) status.
• Higher than normal blood prolactin levels
• Abnormal electrocardiogram results