A Study for Patients With Schizophrenia

Lilly

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: LY2140023; Drug: Olanzapine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00520923

H8Y-MC-HBBI

11757

Details and patient eligibility

About

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.

Enrollment: 654 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Some 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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654 participants in 6 patient groups, including a placebo group

1

Experimental group

Description:

160mg of LY2140023, taken orally as 80mg twice daily, for up to 4 weeks.

Treatment:

Drug: LY2140023

Drug: LY2140023

Drug: LY2140023

Drug: LY2140023

2

Experimental group

Description:

80mg of LY2140023, taken orally as 40mg twice daily, for up to 4 weeks.

Treatment:

Drug: LY2140023

Drug: LY2140023

Drug: LY2140023

Drug: LY2140023

3

Experimental group

Description:

40mg of LY2140023, taken orally as 20mg twice daily, for up to 4 weeks.

Treatment:

Drug: LY2140023

Drug: LY2140023

Drug: LY2140023

Drug: LY2140023

4

Experimental group

Description:

10mg of LY2140023, taken orally as 5mg twice daily, for up to 4 weeks.

Treatment:

Drug: LY2140023

Drug: LY2140023

Drug: LY2140023

Drug: LY2140023

5

Placebo Comparator group

Description:

Placebo of LY2140023, taken orally twice daily, for up to 4 weeks.

Treatment:

Drug: Placebo

Drug: Placebo

6

Active Comparator group

Description:

Placebo, taken orally every morning, followed by Olanzapine 15mg taken orally every evening for up to 4 weeks.

Treatment:

Drug: Olanzapine

Drug: Placebo

Drug: Placebo