Official Title: “Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response?”

The primary purpose of this study is to examine whether IV hydrocortisone can speed up the time required for Venlafaxine XR to work.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: venlafaxine XR
• Drug: hydrocortisone

Primary Measures

• To determine if treatment of major depression with hydrocortisone concurrent with starting venlafaxine XR speeds onset of antidepressant action.

Secondary Measures

• To determine if hydrocortisone pre-treatment augments venlafaxine XR response.

• Inclusion Criteria::- outpatients at least 18 years of age
• current major depressive episode
• HDRS greater than or equal to 21
• good physical health Exclusion Criteria:- history of sensitivity, intolerance, or non-response to venlafaxine
• history of sensitivity to hydrocortisone
• history of bipolar 1 illness
• meets DSM-IV criteria for a current or past psychotic disorder
• meets DSM-IV criteria for substance abuse or dependence in previous 6 months
• significant imminent suicide risk
• medical condition that would compromise participation in the study
• woman of child bearing potential not using adequate birth control in the opinion of the investigator

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Stanford University

Overall Clinical Trial Officials and Contacts

Charles DeBattista Principal Investigator Stanford University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00186264

Study ID Number: Wyeth 0600B-100625

ClinicalTrials.gov Identifier: NCT00186264

Health Authority: United States: Institutional Review Board