Mifepristone in Refractory Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Stanford University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186056
First received: September 13, 2005
Last updated: December 23, 2005
Last verified: September 2005
  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 Phase
Depression
Major Depressive Disorder
Drug: Mifepristone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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:
  • Change in Ham-D scores to assess mood response to mifepristone

Secondary Outcome Measures:
  • Change in stress hormone levels pre and post treatment relative to mood response

Estimated Enrollment: 30
Study Start Date: January 2003
Estimated Study Completion Date: December 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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 Department of Psychiatry and Behavioral Sciences
Palo Alto, California, United States, 94305-5723
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Brent H. Solvason, MD Stanford University Department of Psychiatry and Behavioral Sciences
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00186056     History of Changes
Other Study ID Numbers: 78804
Study First Received: September 13, 2005
Last Updated: December 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Stanford University:
Mifepristone
Depression
Mifeprex
RU 486

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

ClinicalTrials.gov processed this record on October 23, 2014