Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074776
Status:
COMPLETED
Last Update Posted:
2012-07-23
First Post:
2003-12-19
Brief Title:
Acute Treatment of Bipolar II Depression
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Acute Treatment of Bipolar II Depression
Status:
COMPLETED
Status Verified Date:
2012-07
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 study will compare the medications lithium and lamotrigine Lamictal in treating depression in individuals with bipolar II disorder
Detailed Description:
Bipolar II disorder BDII is a serious condition characterized by depressive and hypomanic episodes The disability and suicide risk associated with BDII is equal to bipolar I disorder However there are no clinical trials for BDII nor is the treatment of BDII addressed in current treatment guidelines Data suggest that Li and LTG may be effective treatment options for BDII This study will determine the safety effectiveness and tolerability of the two drugs in people with BDII
Participants in this study will be randomly assigned to receive either Li or LTG for 16 weeks Participants will be assessed every 2 weeks One week after study completion participants will have a follow-up visit Measures of depression mania quality of life functioning and participant satisfaction will be taken
Participants in this study will be randomly assigned to receive either Li or LTG for 16 weeks Participants will be assessed every 2 weeks One week after study completion participants will have a follow-up visit Measures of depression mania quality of life functioning and participant satisfaction will be taken
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 |
|---|---|---|---|
| R21MH067055 | NIH | None | None |
| DSIR 83-ATSO | US NIH GrantContract | None | httpsreporternihgovquickSearchR21MH067055 |