Expired Study
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Stanford, California 94305


Purpose:

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


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

Wyeth 0600B-100625


NCT ID:

NCT00186264


Secondary ID:


Study Acronym:


Brief Title:

Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response?


Official Title:

Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response?


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Stanford University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:

Actual


Overall Contact Information

Official Name:Charles DeBattista
Principal Investigator
Stanford University

Study Dates

Start Date:August 2002
Completion Date:April 2006
Completion Type:Actual
Primary Completion Date:April 2006
Primary Completion Type:Actual
Verification Date:October 2019
Last Changed Date:October 2, 2019
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:To determine if hydrocortisone pre-treatment augments venlafaxine XR response.
Safety Issues:False
Outcome Type:Primary Outcome
Measure:To determine if treatment of major depression with hydrocortisone concurrent with starting venlafaxine XR speeds onset of antidepressant action.
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:venlafaxine XR
Intervention Type:Drug
Name:hydrocortisone

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Stanford University
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Wyeth is now a wholly owned subsidiary of Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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