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Mifepristone in Refractory Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hugh Brent Solvason, Stanford University
ClinicalTrials.gov Identifier:
NCT00186056
First received: September 13, 2005
Last updated: February 17, 2017
Last verified: February 2017
  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: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Mifepristone in Refractory Depression

Resource links provided by NLM:


Further study details as provided by 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 13, 2005
Results First Received: October 13, 2016
Last Updated: February 17, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on May 23, 2017