Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00179244
Status:
COMPLETED
Last Update Posted:
2015-06-02
First Post:
2005-09-13
Brief Title:
Risperidone vs Bupropion ER Augmentation of SSRIs in Treatment-Resistant Depression
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University
Study Overview
Official Title:
Risperidone vs Bupropion ER Augmentation of SSRIs in Treatment-Resistant Depression
Status:
COMPLETED
Status Verified Date:
2015-06
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 evaluate the comparative effectiveness of Risperdal risperidone or bupropion ER extended release combined with a SSRI medication and to test the relative safety of the combinations
Detailed Description:
Major depression is a severe disorder with serious consequences Effective treatments are available however in clinical trials 30-40 of patients do not experience even a 50 reduction in depression severity scores while 50-70 fail to achieve a full therapeutic response Futhermore impairment from the disorder continues essentially unabated in patients who are treated but do not fully remit If anything the situation is at least as bad or not worse in clinical practice Clearly alternatives are needed to manage this common clinical condition
The addition of bupropion ER extended release to an SSRI has empirical support and has become the most common augmentation strategy in the US A comparative trial of the combination of risperidone or bupropion ER added to an SSRI in treatment resistant deperssion could help support risperidone for this condition such a trial seems warranted at this time
Patients who are currently on a SSRI at an adequate dosage for at least 3 weeks with no response will be randomly assigned open-label to either risperidone or bupropion ER augmentation for a period of 6 weeks Patients will be followed weekly at the beginning and bi-weekly towards the end of the trial to compare the response of each group
The addition of bupropion ER extended release to an SSRI has empirical support and has become the most common augmentation strategy in the US A comparative trial of the combination of risperidone or bupropion ER added to an SSRI in treatment resistant deperssion could help support risperidone for this condition such a trial seems warranted at this time
Patients who are currently on a SSRI at an adequate dosage for at least 3 weeks with no response will be randomly assigned open-label to either risperidone or bupropion ER augmentation for a period of 6 weeks Patients will be followed weekly at the beginning and bi-weekly towards the end of the trial to compare the response of each group
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 |
|---|---|---|---|
| 040309 | None | None | None |