Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198198
Status:
COMPLETED
Last Update Posted:
2007-04-05
First Post:
2005-09-14
Brief Title:
Aripiprazole Treatment of Bipolar Depression
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
Official Title:
Open Label Pilot Study of Aripiprazole Treatment of Difficult to Treat Bipolar Depression
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:
This is a study of addition of aripirazole to the treatment of bipolar depressed patients who are not better on the medications that they are currently receiving
Detailed Description:
HypothesisObjectives
Aim 1 To investigate whether aripiprazole is effective in the treatment of bipolar depression
Hypothesis 1 Aripiprazole will lead to a significant decrease in scores on the Hamilton Depression Rating Scale HAM-D during an 8-week treatment course
a Study Population
A total number of 10 evaluable patients will be enrolled in the study
c Study Design and Method
This proposal will use an open label design Aripiprazole will be added to the treatment of patients with DSM-IV American Psychiatric Association 1994 BDD Patients will be allowed to continue their psychotropic medication at a stable dose as long as they meet inclusion criteria as described below Aripiprazole will be started at a dose of 10 mg for two weeks 15 mg for an additional two weeks and 20 mg for the last four weeks The length of time a patient stays on the maximum dose 20 mg depends upon the patients tolerance and treatment response Treatment will continue for 8 weeks with weekly visits and ratings on the 17-item Hamilton Depression Rating Scale HAM-D 17 and other ratings scales
Aim 1 To investigate whether aripiprazole is effective in the treatment of bipolar depression
Hypothesis 1 Aripiprazole will lead to a significant decrease in scores on the Hamilton Depression Rating Scale HAM-D during an 8-week treatment course
a Study Population
A total number of 10 evaluable patients will be enrolled in the study
c Study Design and Method
This proposal will use an open label design Aripiprazole will be added to the treatment of patients with DSM-IV American Psychiatric Association 1994 BDD Patients will be allowed to continue their psychotropic medication at a stable dose as long as they meet inclusion criteria as described below Aripiprazole will be started at a dose of 10 mg for two weeks 15 mg for an additional two weeks and 20 mg for the last four weeks The length of time a patient stays on the maximum dose 20 mg depends upon the patients tolerance and treatment response Treatment will continue for 8 weeks with weekly visits and ratings on the 17-item Hamilton Depression Rating Scale HAM-D 17 and other ratings scales
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 |
|---|---|---|---|
| 0402-46 | None | None | None |