Status:
COMPLETED
Mifepristone in Refractory Depression
Lead Sponsor:
Stanford University
Conditions:
Depression
Eligibility:
All Genders
18-75 years
Phase:
NA
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 af...
Detailed Description
Study Procedures: This study will be a double-blind placebo-controlled 5-week trial. Thirty patients with treatment refractory major depression will be studied over a one year period. Patients will ...
Eligibility Criteria
Inclusion
- :
- 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
- 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.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00186056
Start Date
January 1 2003
End Date
May 1 2007
Last Update
April 5 2017
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305