Hydrocortisone and venlafaxine XR in Depressive Disorder, Major - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Depressive Disorder, Major

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Stanford, California, United States, 94305
    - Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Principal Investigator: Charles DeBattista, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2002

Primary Completion (ACTUAL)

April 1, 2006

Study Completion (ACTUAL)

April 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria