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
Information provided by:
First received: September 13, 2005
Last updated: December 23, 2005
Last verified: September 2005
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.
Major Depressive Disorder
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
||Mifepristone in Refractory Depression
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:
| Study Start Date:
| Estimated Study Completion Date:
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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
|Stanford University Department of Psychiatry and Behavioral Sciences
|Palo Alto, California, United States, 94305-5723 |
||Brent H. Solvason, MD
||Stanford University Department of Psychiatry and Behavioral Sciences
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 13, 2005
||December 23, 2005
||United States: Food and Drug Administration
Keywords provided by Stanford University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2015
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Abortifacient Agents, Steroidal
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital, Synthetic
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents