Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response?

NCT00186264

Last updated date
Study Location
Stanford University School of Medicine
Stanford, California, 94305, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

:- outpatients at least 18 years of age

- current major depressive episode

- HDRS greater than or equal to 21

- good physical health

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response?
Official Title  ICMJE Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response?
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE
  • Drug: venlafaxine XR
  • Drug: hydrocortisone
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 2, 2019)
18
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
20
Actual Study Completion Date  ICMJE April 2006
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00186264
Other Study ID Numbers  ICMJE Wyeth 0600B-100625
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Charles DeBattista, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Charles DeBattistaStanford University
PRS Account Stanford University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP