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NCT00520923

PHASE2

A Study for Participants With Schizophrenia

Sponsor: Denovo Biopharma LLC

View on ClinicalTrials.gov

Summary

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.

Official title: A Multi-Center, Inpatient, Phase 2, Double-blind, Placebo-Controlled Dose Ranging Study of LY2140023 in Patients With DSM-IV Schizophrenia

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

669

Start Date

2007-09

Completion Date

2008-10

Last Updated

2026-09-14

Healthy Volunteers

Conditions

Schizophrenia

Interventions

DRUG

LY2140023

Administered orally

DRUG

Olanzapine

Administered orally

DRUG

Placebo

Administered orally

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.

Locations (35)

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.

Banfield, Argentina

Buenos Aires, Argentina

Lanus, Argentina

Munro, Argentina

Graz, Austria

Vienna, Austria

Osijek, Croatia

Split, Croatia

Zagreb, Croatia

Aachen, Germany

Bochum, Germany

Dresden, Germany

München, Germany

Mexico City, Mexico

Monterrey, Mexico

Lisbon, Portugal

Porto, Portugal

Bucharest, Romania

Craiova, Romania

Iași, Romania

Târgu Mureş, Romania

Kazan', Russia

Khot'kovo, Russia

Lipetsk, Russia

Moscow, Russia

Nikol’skoye, Russia

Nizhny Novgorod, Russia

Saint Petersburg, Russia

Samara, Russia

Bloemfontein, South Africa

Cape Town, South Africa

Durban, South Africa

Johannesburg, South Africa

Pretoria, South Africa

Randburg, South Africa

Clinical Research Directory

A Study for Participants With Schizophrenia

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (35)