Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia

• ClinicalTrials.gov Identifier: NCT00051298
• Recruitment Status: Completed
• First Posted: January 9, 2003
• Last Update Posted: June 12, 2007
• Sponsor: Eli Lilly and Company
• Information provided by: Eli Lilly and Company

Tracking Information

• First Submitted Date: January 7, 2003
• First Posted Date: January 9, 2003
• Last Update Posted Date: June 12, 2007
• Study Start Date: November 2002
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: June 11, 2007): 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
• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: June 11, 2007)

• Assess secondary efficacy measures to capture additional evidence of efficacy utilizing the CGI-I, CGI-S, PANSS and OAS
• Assess the efficacy of olanzapine compared with placebo in improving clinical symptomatology in terms of rate of response
• 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.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia
• Official Title: Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Schizophrenia

Intervention

• Drug: Olanzapine
• Drug: Placebo

• Study Arms: Not Provided

Publications *

• Kryzhanovskaya LA, Robertson-Plouch CK, Xu W, Carlson JL, Merida KM, Dittmann RW. The safety of olanzapine in adolescents with schizophrenia or bipolar I disorder: a pooled analysis of 4 clinical trials. J Clin Psychiatry. 2009 Feb;70(2):247-58. Epub 2009 Feb 10. Erratum in: J Clin Psychiatry. 2009 Dec;70(12):1729.
• Kryzhanovskaya L, Schulz SC, McDougle C, Frazier J, Dittmann R, Robertson-Plouch C, Bauer T, Xu W, Wang W, Carlson J, Tohen M. Olanzapine versus placebo in adolescents with schizophrenia: a 6-week, randomized, double-blind, placebo-controlled trial. J Am Acad Child Adolesc Psychiatry. 2009 Jan;48(1):60-70. doi: 10.1097/CHI.0b013e3181900404.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 11, 2007): 107
• Original Enrollment: Not Provided
• Actual Study Completion Date: April 2005
• Primary Completion Date: Not Provided

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 13 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Russian Federation, United States

Administrative Information

• NCT Number: NCT00051298
• Other Study ID Numbers: 4066; F1D-MC-HGIN
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Eli Lilly and Company
• Collaborators: Not Provided

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST); Eli Lilly and Company

• PRS Account: Eli Lilly and Company
• Verification Date: June 2007