Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-25 @ 4:29 PM
Study NCT ID:
NCT00844857
Status:
COMPLETED
Last Update Posted:
2013-02-18
First Post:
2009-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
Study to Assess the Efficacy and Safety of Olanzapine and Fluoxetine Combination Versus Placebo in Patients Ages 10-17 in the Treatment of Major Depressive Episodes Associated With Bipolar I Disorder
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main goal of this study is to help answer the following research question(s) and not to treat the child's illness.
* Can this study drug make children with bipolar depression feel better?
* Does this study drug work better than a placebo (sugar pill)?
* Does this study drug cause side effects in children who take it?
* Is this drug safe to use in children? (The study drug is a mixture of olanzapine and fluoxetine)
* Can this study drug make children with bipolar depression feel better?
* Does this study drug work better than a placebo (sugar pill)?
* Does this study drug cause side effects in children who take it?
* Is this drug safe to use in children? (The study drug is a mixture of olanzapine and fluoxetine)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| H6P-MC-HDAX | OTHER | Eli Lilly and Company | View |