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| 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 |
| Drug Information available for: | Olanzapine |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |||||
| Eli Lilly and Company |
| 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 
  |
| 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 |
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