Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510146
Status:
COMPLETED
Last Update Posted:
2011-05-26
First Post:
2007-07-30
Brief Title:
Olanzapine Treatment of Patients With Bipolar I Disorder
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
Efficacy and Safety of Olanzapine in the Treatment of Patients With Bipolar I Disorder Depressed A Randomized Double-Blind Comparison With Placebo
Status:
COMPLETED
Status Verified Date:
2011-04
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 purpose of this study is to assess whether olanzapine is superior to placebo in patients with bipolar depression
Detailed Description:
1 Dose range and administration mode Oral Olanzapine 5mg - 20mgday
2 Duration
1 Screening phase is 2-28 days
2 Double-blind treatment phase is 6 weeks
3 Open-label extension phase is 18 weeks
2 Duration
1 Screening phase is 2-28 days
2 Double-blind treatment phase is 6 weeks
3 Open-label extension phase is 18 weeks
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| F1D-MC-HGMP | OTHER | Eli Lilly and Company | None |