A Study for Patients With Schizophrenia

Phase 2

Completed

Brief Summary: The purpose of this study is to test the hypothesis that 1 or more dose levels of LY2140023 given orally to patients with schizophrenia twice daily for 4 weeks will have significantly greater effect than placebo.

Recruitment & Eligibility

Inclusion Criteria

Patients must have a diagnosis of Schizophrenia as defined in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (Disorganized, 295.10; Catatonic, 295.20; Paranoid, 295.30; Residual, 295.60; or Undifferentiated, 295.90) and confirmed by the Structured Clinical Interview for DSM-IV (SCID).
Patients must meet the following psychopathologic severity criteria at Visit 1: Brief Psychiatric Rating Scale (BPRS) total score, extracted from the Positive and Negative Syndrome Scale (PANSS), of at least 45 (18-item version, in which 1 indicates "absent" and 7 indicates "severe"). In addition, item scores of at least 4 (moderate) will be required on 2 of the following BPRS items: conceptual disorganization, suspiciousness, hallucinatory behavior, and/or unusual thought content.
Patients must receive a rating of 4 (moderately ill) or greater on the Clinical Global Impression-Severity (CGI-S) scale at Visit 1.
Patients in whom, in the opinion of the investigator, a switch to another antipsychotic medication or initiation of an antipsychotic medication is acutely indicated.

Some

Exclusion Criteria

Patients in whom treatment with olanzapine or placebo is relatively or absolutely clinically contraindicated.
Patients who have a history of inadequate response to an adequate treatment trial with olanzapine, in the opinion of the investigator.
Patients who have received treatment with olanzapine within 6 weeks prior to Visit 1.
Patients who have received treatment with clozapine at doses greater than 200 mg daily within 12 months prior to Visit 1, or who have received any clozapine at all during the month before Visit 1.
Patients who have a history of an inadequate response, in the opinion of the investigator, to 2 or more adequate antipsychotic medication trials of at least 8 weeks duration in the past 12 months prior to Visit 1.
Patients with acute, serious, or unstable medical conditions, including (but not limited to) inadequately controlled diabetes (hemoglobin A1c (HbA1c) 8%), severe hypertriglyceridemia (fasting triglycerides 5.6 mmol/L, recent cerebrovascular accidents, serious acute systemic infection or immunologic disease, unstable cardiovascular disorders (including ischemic heart disease), malnutrition, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, or hematologic diseases.

Arm && Interventions

Group	Intervention	Description
1	LY2140023	160mg of LY2140023, taken orally as 80mg twice daily, for up to 4 weeks.
2	LY2140023	80mg of LY2140023, taken orally as 40mg twice daily, for up to 4 weeks.
3	LY2140023	40mg of LY2140023, taken orally as 20mg twice daily, for up to 4 weeks.
4	LY2140023	10mg of LY2140023, taken orally as 5mg twice daily, for up to 4 weeks.
5	Placebo	Placebo of LY2140023, taken orally twice daily, for up to 4 weeks.
6	Placebo	Placebo, taken orally every morning, followed by Olanzapine 15mg taken orally every evening for up to 4 weeks.
6	Olanzapine	Placebo, taken orally every morning, followed by Olanzapine 15mg taken orally every evening for up to 4 weeks.

Primary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale (PANSS) total score	over 4 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
PANSS subscores: positive subscore; negative subscore; general psychopathology subscore and cognitive subscore	over 4 weeks of treatment
Clinical Global Impression-Severity (CGI-S)	over 4 weeks of treatment
Drug Attitude Inventory-10 (DAI-10)	over 4 weeks of treatment
Response and Remission Rates	over 4 weeks of treatment
Assessment of Cognition in Schizophrenia (BACS) Symbol Coding Task	over 4 weeks of treatment
Montgomery-Asberg Depression RatingScale (MADRS)	over 4 weeks of treatment
Safety and Tolerability	over 4 weeks of treatment
Pharmacokinetics	over 4 weeks of treatment

Locations (1): For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Randburg, South Africa