Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-28 @ 11:26 AM
Study NCT ID:
NCT00723450
Status:
COMPLETED
Last Update Posted:
2017-01-09
First Post:
2008-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
The Evaluation of Lamictal as an Add-on Treatment for Bipolar I Disorder in Children and Adolescents, 10 to 17 Years of Age
Status:
COMPLETED
Status Verified Date:
2016-11
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 study will be a multi-center, parallel, group, placebo control, double-blind, randomized controlled trial of lamictal as add-on maintenance treatment in pediatric outpatients (aged 10 to 17 years) diagnosed with Bipolar I disorder. The study consists of 4 phases: Screen (approximately 2 weeks), Open label phase (up to 18 weeks), Randomized phase (up to 36 weeks) and Taper and follow-up phase (up to 4 weeks).
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?: