Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226135
Status:
COMPLETED
Last Update Posted:
2007-04-05
First Post:
2005-09-23
Brief Title:
Prophylactic Effect of Lamotrigine Compared With Lithium in Bipolar Disorder
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Lamotrigine Versus Lithium in Subjects With Bipolar Affective Disorders - a Randomised Study of Prophylactic Effect
Status:
COMPLETED
Status Verified Date:
2007-04
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 compare lamotrigine with lithium in the long term treatment of bipolar disorder in terms of new episode preventive potentials
Detailed Description:
Bipolar disorder is a recurrent lifelong illness Lithium is still the drug of first choice in the prophylactic treatment However lithiums side effects are considerable Thus the interest in developing alternatives to lithium has increased and various antiepileptic drugs have been studied Among these lamotrigine which generally is well tolerated has been evaluated in industry generated trials However for various reasons the generalisability of the results from these studies is limited Also the follow-up time is limited This study is a pragmatic effectiveness study overcoming some of these limitations and comparing lamotrigine with that of lithium in terms of their potentials for preventing new episodes in patients 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 98-rc-316 | None | None | None |