Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response? - Full Text View

Sponsors and Collaborators:	Stanford University Wyeth
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00186264

Purpose

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

Condition	Intervention
Depressive Disorder, Major	Drug: venlafaxine XR Drug: hydrocortisone

MedlinePlus related topics: Antidepressants Depression Methamphetamine

Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Venlafaxine Venlafaxine hydrochloride Amphetamine Methamphetamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response?

Further study details as provided by Stanford University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	20
Study Start Date:	August 2002
Estimated Study Completion Date:	April 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00186264

Locations

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

Sponsors and Collaborators

Stanford University

Wyeth

Investigators

Principal Investigator:

Charles DeBattista

Stanford University

More Information

Study ID Numbers:	Wyeth 0600B-100625
Study First Received:	September 13, 2005
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00186264
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Depression
Hydrocortisone
Cortisol succinate
Depressive Disorder, Major
Depressive Disorder
Serotonin
Behavioral Symptoms

Methamphetamine
Mental Disorders
Venlafaxine
Mood Disorders
Amphetamine
Hydrocortisone acetate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors

Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 15, 2009