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Sponsors and Collaborators: |
Stanford University Wyeth |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00186264 |
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 |
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Depressive Disorder, Major |
Drug: venlafaxine XR Drug: hydrocortisone |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Does Concurrent Hydrocortisone With Venlafaxine XR Speed Antidepressant Response? |
Estimated Enrollment: | 20 |
Study Start Date: | August 2002 |
Estimated Study Completion Date: | April 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria::- outpatients at least 18 years of age
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Charles DeBattista | Stanford University |
Study ID Numbers: | Wyeth 0600B-100625 |
Study First Received: | September 13, 2005 |
Last Updated: | December 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00186264 History of Changes |
Health Authority: | United States: Institutional Review Board |
Anti-Inflammatory Agents Neurotransmitter Agents Depression Hydrocortisone Cortisol succinate Psychotropic Drugs Depressive Disorder, Major Depressive Disorder Serotonin Uptake Inhibitors Serotonin |
Behavioral Symptoms Methamphetamine Mental Disorders Venlafaxine Mood Disorders Amphetamine Hydrocortisone acetate Antidepressive Agents, Second-Generation Antidepressive Agents |
Anti-Inflammatory Agents Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Depression Hydrocortisone Molecular Mechanisms of Pharmacological Action Cortisol succinate Physiological Effects of Drugs Psychotropic Drugs Depressive Disorder, Major Depressive Disorder Serotonin Uptake Inhibitors |
Pharmacologic Actions Behavioral Symptoms Serotonin Agents Mental Disorders Therapeutic Uses Venlafaxine Mood Disorders Hydrocortisone acetate Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |