Olanzapine Versus Placebo in the Treatment of Mania in Adolescents With Bipolar I Disorder
Information source: Eli Lilly and Company
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: Olanzapine (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company
Summary
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.
Clinical Details
Official title: Olanzapine Versus Placebo in the Treatment of Mania in Adolescents With Bipolar I Disorder
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: 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
Eligibility
Minimum age: 13 Years.
Maximum age: 17 Years.
Gender(s): Both.
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.
Locations and Contacts
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
Additional Information
Lilly Clinical Trial Registry
Starting date: November 2002
Ending date: May 2005
Last updated: June 11, 2007
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