Olanzapine Versus Placebo in the Treatment of Mania in Adolescents With Bipolar I Disorder
Completed · Phase 4 · Has a placebo group
Conditions studied: Bipolar Disorder
In brief
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.
Key facts
- Study ID
- NCT00050206
- Run by
- Eli Lilly and Company
- People needed
- 130
- Starts
- 2002-11-01
- Expected to finish
- 2005-05-01
- Last updated by the study team
- 2007-06-12
Who can join
Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.