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Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Stanford University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186264
First received: September 13, 2005
Last updated: December 14, 2007
Last verified: December 2007
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response?

Resource links provided by NLM:

U.S. FDA Resources

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 is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Charles DeBattista Stanford University
  More Information

No publications provided

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

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Venlafaxine
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
 Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Dermatologic Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on May 22, 2013