Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224510
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2005-09-21
Brief Title:
A Study To Investigate The Antidepressant Effect Of Lamotrigine In Patients With Bipolar Disorder Using Lithium
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Mulitcentre Double-blind Randomised Fixed-dose Evaluation of the Safety and Efficacy of Lamictal Lamotrigine Compared to Placebo as an add-on Therapy to Lithium or Another Mood Stabiliser in the Treatment of Bipolar Depression Followed by Long-term Prevention of Relapse and Recurrence of Depression andor Mania in Patients With Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2017-05
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:
This is a study that in the first 16 weeks investigates whether lamotrigine versus placebo offers effect on depressive episodes for patients with bipolar disorder also known as manic depressive disorder who use lithium In the following 50 weeks it is investigated whether these patients experience effect on their depressive and or hypomanic episodes
Detailed Description:
A Multicentre Double-Blind Randomised Fixed-Dose Evaluation of the Safety and Efficacy of Lamotrigine Lamictal compared to placebo as add-on therapy to lithium in the Treatment of Bipolar Depression followed by Long-term Prevention of Relapse and Recurrence of Depression andor Mania in Subjects With Bipolar Disorder
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