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Olanzapine Versus Placebo in the Treatment of Mania in Adolescents With Bipolar I Disorder

This study has been completed.

Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00050206
  Purpose

The purpose of 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 mania in bipolar disorder in adolescents. Both the potential benefits and side effects of olanzapine will be evaluated throughout this trial.


Condition Intervention Phase
Bipolar Disorder
Drug: Olanzapine
Drug: Placebo
Phase IV

MedlinePlus related topics:   Bipolar Disorder   

ChemIDplus related topics:   Olanzapine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Olanzapine Versus Placebo in the Treatment of Mania in Adolescents With Bipolar I Disorder

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Assess the efficacy of a flexible dose of olanzapine compared with placebo in the treatment of mania in bipolar I disorder (manic or mixed episode associated with bipolar I disorder, with or without psychotic features) in adolescents

Secondary Outcome Measures:
  • Assess additional efficacy as measured by Y-MRS,CGI-BP Severity of Illness, CGI-BP Severity of Illness (CGI-BP Severity of Mania, CGI-BP Severity of Depression, and CGI-BP Severity Overall)
  • Assess additional efficacy as measured by Children’s Depression Rating Scale-Revised (CDRS- R);Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IVPI) and Overt Aggression Scale (OAS).
  • Assess the safety of olanzapine and quality of life associated with olanzapine compared with placebo.
  • Compare the frequency of response of up to 3-weeks, double-blind treatment and up to an additional 26 weeks of open-label olanzapine treatment

Estimated Enrollment:   130
Study Start Date:   November 2002
Study Completion Date:   May 2005

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

Criteria

Inclusion Criteria:

  • Male or female patients, 13 to 17 years of age who must not yet have reached their 18th birthday prior to Visit 1, when informed consent is obtained.
  • Patients must have a diagnosis of bipolar I disorder and currently display an acute mania or mixed episode.
  • 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.
  • Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test.

Exclusion Criteria:

  • Female patients who are either pregnant or nursing.
  • Current diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder.
  • Patient with acute or unstable medical conditions, such that intensive care unit hospitalization for the disease is anticipated within 6 months.
  • Patients who have previously not responded to an adequate dose and/or duration of olanzapine treatment.
  • Patients who have been judged clinically to be serious suicidal risks.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050206

Locations
United States, Indiana
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.    
      Indianapolis, Indiana, United States

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

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

Publications indexed to this study:

Study ID Numbers:   4360, F1D-MC-HGIU
First Received:   November 26, 2002
Last Updated:   June 11, 2007
ClinicalTrials.gov Identifier:   NCT00050206
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Olanzapine
Mood Disorders
Psychotic Disorders
Serotonin

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 05, 2008




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