Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response?

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00186264
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Enrollment: 18
• Location: 1
• Actual Duration (Months): 44
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder, Major	Drug: venlafaxine XR; Drug: hydrocortisone	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response?
• Actual Study Start Date: Aug 1, 2002
• Actual Primary Completion Date: Apr 1, 2006
• Actual Study Completion Date: Apr 1, 2006

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. To determine if hydrocortisone pre-treatment augments venlafaxine XR response. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University
• Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Principal Investigator: Charles DeBattista, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Charles DeBattista, Professor of Psychiatry and Behavioral Sciences, Stanford University
• ClinicalTrials.gov Identifier: NCT00186264
• Other Study ID Numbers: Wyeth 0600B-100625
• First Posted: Sep 16, 2005
• Last Update Posted: Oct 4, 2019
• Last Verified: Oct 1, 2019

• Additional relevant MeSH terms: Depressive Disorder; Depressive Disorder, Major; Hydrocortisone; Venlafaxine Hydrochloride

Study Results

No Results Posted as of Oct 4, 2019