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Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00051298
Recruitment Status : Completed
First Posted : January 9, 2003
Last Update Posted : June 12, 2007
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE January 7, 2003
First Posted Date  ICMJE January 9, 2003
Last Update Posted Date June 12, 2007
Study Start Date  ICMJE November 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Olanzapine
  • Drug: Placebo
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2007)
107
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00051298
Other Study ID Numbers  ICMJE 4066
F1D-MC-HGIN
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP