Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360126
Status:
COMPLETED
Last Update Posted:
2017-03-30
First Post:
2006-08-02
Brief Title:
An Open-Label Extension Study Of Lamotrigine In Subjects With Bipolar Disorder
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
An Open-Label Extension Study to Assess the Safety of Lamotrigine in Subjects With Bipolar Disorder Who Are in Remission Following a ManicHypomanic Index Episode or a Depressive Index Episode
Status:
COMPLETED
Status Verified Date:
2017-02
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 precursor study SCA101469 was an open-label prospective multicentre study in adult subjects diagnosed with bipolar disorder consisting of 36 weeks treatment with lamotrigine The current study is to provide 12 months post study access to open-label lamotrigine for participants of the SCA101469 study
Detailed Description:
None
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