Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia

Phase 3

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00051298
• Lead Sponsor: Eli Lilly and Company

Brief Summary

This study is to determine the efficacy (how well the drug works), safety, and any side effects of olanzapine compared to placebo in the treatment of schizophrenia in adolescents. Both the potential benefits and side effects of olanzapine will be evaluated throughout this trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2003-01-07
• Study First Submitted QC: 2003-01-08
• Study First Posted: 2003-01-09
• Study Completion: 2005-04
• Status Verified: 2007-06
• Last Update Submitted: 2007-06-11
• Last Update Posted: 2007-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• Are male or female patients, 13 to 17 years of age
• Patients must have a diagnosis of schizophrenia per DSM-IV-TR.
• Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment.
• Both the patient and the patient's parent/authorized legal representative must understand the nature of the study and must sign a document granting consent.
• Patients must be capable of swallowing study medication whole (without crushing, dissolving, etc.)

Exclusion Criteria

• Female patients who are either pregnant or nursing.
• Patients with acute or unstable medical conditions.
• Patients who have been judged clinically to be at serious suicidal risks.
• Patients who have previously not responded to an adequate dose and/or duration of olanzapine treatment.
• Patients who currently have delusional disorder, psychotic disorder NOS, schizophreniform, schizoaffective disorder, bipolar disorder, attention deficit/hyperactivity disorder or major depressive disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assess the efficacy of a flexible dose of olanzapine compared to placebo in the treatment of adolescents (ages 13 - 17) with schizophrenia using the BPRS-C

Secondary Outcome Measures

Name	Time	Method
Assess secondary efficacy measures to capture additional evidence of efficacy utilizing the CGI-I, CGI-S, PANSS and OAS
Assess the safety of olanzapine compared with placebo for up to 6 weeks of double-blind treatment and for up to an additional 26 weeks of open-label olanzapine treatment.
Assess the health-related quality of life and cognition associated with olanzapine compared with placebo for up to 6 weeks of double-blind treatment and for up to an additional 26 weeks of open-label olanzapine treatment.
Assess the efficacy of olanzapine compared with placebo in improving clinical symptomatology in terms of rate of response

Trial Locations

Locations (2)

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 hrs, EST), or speak with your personal physician.; 🇷🇺 Moscow, Russian Federation

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician; 🇺🇸 Cerritos, California, United States