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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050206
• Other study ID #: 4360
• Secondary ID: F1D-MC-HGIU
• Status: Completed
• Phase: Phase 4
• First received: November 26, 2002
• Last updated: June 11, 2007
• Start date: November 2002
• Est. completion date: May 2005

Study information

• Verified date: June 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Olanzapine

• Placebo

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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).
Secondary	Assess the safety of olanzapine and quality of life associated with olanzapine compared with placebo.
Secondary	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

External Links

•   Lilly Clinical Trial Registry