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Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00186264
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : October 4, 2019
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Charles DeBattista, Stanford University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : August 2002
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006





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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00186264


Locations
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United States, California
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
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Principal Investigator: Charles DeBattista Stanford University

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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: September 16, 2005    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Antidepressive Agents
Venlafaxine Hydrochloride
Psychotropic Drugs
Anti-Inflammatory Agents
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation