Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response?
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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
Depressive Disorder, Major
Drug: venlafaxine XRDrug: hydrocortisone
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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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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