Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response?
Recruitment status was Active, not recruiting
The primary purpose of this study is to examine whether IV hydrocortisone can speed up the time required for Venlafaxine XR to work.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response?|
- To determine if treatment of major depression with hydrocortisone concurrent with starting venlafaxine XR speeds onset of antidepressant action.
- To determine if hydrocortisone pre-treatment augments venlafaxine XR response.
|Study Start Date:||August 2002|
|Estimated Study Completion Date:||April 2006|
Participants will be treated with Venlafaxine XR for 6 weeks. The dose of Venlafaxine XR will begin at 37.5 mg/day and be gradually increased to a maximum of 225 mg/day. The dose may be kept as low as 75 mg/day 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.
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Charles DeBattista||Stanford University|