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Mifepristone in Refractory Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00186056
First Posted: September 16, 2005
Last Update Posted: April 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hugh Brent Solvason, Stanford University
  Purpose
The purpose of the study is to examine the effectiveness of mifepristone treatment in patients with refractory depression. Refractory depression is defined as clinical depression that is unimproved after treatment with at least 2 different antidepressants of adequate dose and time trial. Mifepristone will augment current medications.

Condition Intervention
Depression Drug: Mifepristone Drug: Placebo Oral Tablet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mifepristone in Refractory Depression

Resource links provided by NLM:


Further study details as provided by Hugh Brent Solvason, Stanford University:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale [ Time Frame: Baseline and Day 35 HAMD scores ]

    Hamilton Depression Rating Scale. Minimum score of 0 (no depressive symptoms) to maximum of 68 (very severely depressed).

    Outcome Measure is reporting a Change from Baseline in HAMD scores, i.e., scores at Day 35 minus scores at Baseline.



Enrollment: 31
Study Start Date: January 2003
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mifepristone
Patients received mifepristone for 6 days
Drug: Mifepristone
Glucocorticoid antagonist
Other Name: RU 486
Placebo Comparator: placebo
Patients received placebo for 6 days
Drug: Placebo Oral Tablet
Inactive placebo tab
Other Name: sugar pill

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria::

  • 21-item HAM-D score of 20 or above.
  • If currently taking antipsychotic, antidepressant, anticonvulsant, and/or mood-stabilizing medications, must be stable on the medication for at least three weeks prior to entering the study.
  • At least 2 failed antidepressant medication trials of adequate dose and duration.
  • Between 18 and 75 years of age.
  • Not currently pregnant or trying to become pregnant.

Exclusion Criteria:-History of schizophrenia or other psychotic disorders.

  • Transcranial magnetic stimulation treatment or ECT in the 3 months prior to starting the study.
  • History of vagus nerve stimulation treatment.
  • No unstable or untreated cardiovascular disease, hypertension, or endocrine disorder.
  • Current use of oral contraceptives or any other drug that may result in adverse drug-mifepristone interactions effects (including Amiodarone, Clarithromycin, Erythromycin, Fluconazole, Fluvoxamine, Indinavir, Intraconazole, Ketoconazole, Metronidazole, Miconazole, Nefazodone, Nelfinavir, Norfloxacin, Omeprazole, Quinine, Ritonavir, Saquinavir, Troleandomycin, Zafirlukast, Carbamazepine, Dexamethasone, Ethosuximide, Phenobarbital, Phenytoin, Primidone, Rifabutin, Rifampin, Troglitazone). A 30-day wash-out period for oral contraceptives is required before mifepristone begins.
  • Previous allergic reaction to mifepristone or drugs of similar chemical structure.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00186056


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Hugh Brent Solvason Stanford University
  More Information

Responsible Party: Hugh Brent Solvason, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00186056     History of Changes
Other Study ID Numbers: 78804
First Submitted: September 13, 2005
First Posted: September 16, 2005
Results First Submitted: October 13, 2016
Results First Posted: April 5, 2017
Last Update Posted: April 5, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents