Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00051298

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: Olanzapine Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Olanzapine

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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:

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.

Enrollment:	107
Study Start Date:	November 2002
Study Completion Date:	April 2005

Eligibility

Ages Eligible for Study:	13 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051298

Show 25 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

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

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

ClinicalTrials.gov Identifier:	NCT00051298 History of Changes
Other Study ID Numbers:	4066, F1D-MC-HGIN
Study First Received:	January 7, 2003
Last Updated:	June 11, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Olanzapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 24, 2012