NCT00186264

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

October 4, 2019

Status Verified

October 1, 2019

Enrollment Period

3.7 years

First QC Date

September 13, 2005

Last Update Submit

October 2, 2019

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

venlafaxine XRDRUG
hydrocortisoneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • current major depressive episode
  • HDRS greater than or equal to 21

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Officials

  • Charles DeBattista

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

August 1, 2002

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

October 4, 2019

Record last verified: 2019-10

Locations

US(1)