Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00186264
Status:
COMPLETED
Last Update Posted:
2019-10-04
First Post:
2005-09-13
Brief Title:
Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response
Status:
COMPLETED
Status Verified Date:
2019-10
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 primary purpose of this study is to examine whether IV hydrocortisone can speed up the time required for Venlafaxine XR to work
Detailed Description:
Participants will be treated with Venlafaxine XR for 6 weeks The dose of Venlafaxine XR will begin at 375 mgday and be gradually increased to a maximum of 225 mgday The dose may be kept as low as 75 mgday if necessary Study doctor will be assessing mood to determine if some patients respond more quickly than the several weeks often required for an antidepressant to begin working On the first day of treatment with Venlafaxine XR participant will be randomly assigned similar to a flip of a coin to receive hydrocortisone 15 mg day or placebo for two days Placebo is an inactive substance like a sugar pill This dose of hydrocortisone is less than a typical replacement dose for patients who are not producing cortisol hydrocortisone naturally The hydrocortisone is administered intravenously in a vein over the course of 2 hours for two consecutive days Neither participant nor study doctor will know which treatment participant is receiving However this information is available to study doctor if it is needed
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