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Mifepristone in Refractory Depression

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ClinicalTrials.gov Identifier: NCT00186056
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : April 5, 2017
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Hugh Brent Solvason, Stanford University

Brief Summary:
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 or disease Intervention/treatment Phase
Depression Drug: Mifepristone Drug: Placebo Oral Tablet Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mifepristone in Refractory Depression
Study Start Date : January 2003
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.




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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.

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

Responsible Party: Hugh Brent Solvason, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00186056     History of Changes
Other Study ID Numbers: 78804
First Posted: September 16, 2005    Key Record Dates
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