A Study for Participants With Schizophrenia

Phase 2CompletedNCT00520923

Denovo Biopharma LLC669 enrolled

Overview

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

The primary objective of this study was to test the hypothesis that 1 or more dose levels of LY2140023 given orally to patients with schizophrenia twice daily for 4 weeks would demonstrate significantly greater efficacy than placebo. Efficacy was defined as clinical response measured by the Positive and Negative Syndrome Scale (PANSS) total score as assessed at 4 weeks. This was a multi-center, randomized, double-blind, parallel, placebo- and active comparator-controlled trial with 4 study periods. Approximately 870 patients who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV, APA 2000) criteria for schizophrenia as defined by the modified Structured Clinical Interview for DSM-IV Diagnosis (SCID) were to be entered into the study so that approximately 550 patients would be considered evaluable (that is, randomized patients with a baseline and at least 1 postbaseline PANSS total score following study treatment). Male and female patients aged 18 to 65 years who qualified for enrollment into the study were randomized in a 2:2:2:2:2:1 ratio to receive 5 mg, 20 mg, 40 mg, or 80 mg twice daily LY2140023, placebo twice daily, or placebo once each morning and 15 mg olanzapine once each evening for approximately 28 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

669

Conditions

Schizophrenia

Interventions

LY2140023DRUG

Administered orally

OlanzapineDRUG

Administered orally

PlaceboDRUG

Administered orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Some Inclusion Criteria: * Participants 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). * Participants 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. * Participants must receive a rating of 4 (moderately ill) or greater on the Clinical Global Impression-Severity (CGI-S) scale at Visit 1. * Participants 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: * Participants in whom treatment with olanzapine or placebo is relatively or absolutely clinically contraindicated. * Participants who have a history of inadequate response to an adequate treatment trial with olanzapine, in the opinion of the investigator. * Participants who have received treatment with olanzapine within 6 weeks prior to Visit 1. * Participants 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. * Participants 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. * Participants 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 millimoles per litre (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.