Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00063362
Status:
TERMINATED
Last Update Posted:
2016-11-06
First Post:
2003-06-25
Brief Title:
Combination Therapy for the Treatment of Bipolar Disorders
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
University Hospitals Cleveland Medical Center
Study Overview
Official Title:
Combination Therapy in Bipolar Rapid Cycling
Status:
TERMINATED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding Expiration
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 triple and double drug regimens in the treatment of patients with depression hypomania or mania
Detailed Description:
Early studies have shown lithium to produce a high percentage of satisfactory clinical response in patients with bipolar disorders These studies however do not include lithium-refractory subgroups such as bipolar II disorder patients When the wide spectrum of bipolar disorders is considered the lithium response rate decreases significantly More broadly effective regimens are needed
Participants in this study will be randomly assigned to receive either lithium plus divalproex or lithium divalproex and lamotrigine for 7 months Symptoms of depression and mania will be assessed with scales and patient questionnaires
Participants in this study will be randomly assigned to receive either lithium plus divalproex or lithium divalproex and lamotrigine for 7 months Symptoms of depression and mania will be assessed with scales and patient questionnaires
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 |
|---|---|---|---|
| R21MH062650 | NIH | None | None |
| DSIR AT-SO | US NIH GrantContract | None | httpsreporternihgovquickSearchR21MH062650 |