Status:
COMPLETED
Mifepristone Treatment for Patients With Non-psychotic Major Depressive Disorder Receiving Bilateral ECT
Lead Sponsor:
Stanford University
Conditions:
Depression
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to see whether the medication mifepristone is an effective and tolerable treatment for increasing the clinical effectiveness of electroconvulsive therapy (ECT) and protect...
Detailed Description
Patients referred to the Stanford ECT Service who provide informed consent for this study will be screened for eligibility. Day -4 to 0: Screening (visit 1) will occur three to six days prior to the ...
Eligibility Criteria
Inclusion
- To be considered for participation in the study, subject must meet all of the following criteria:
- 1\. Meets DSM-IV criteria for Major Depressive Episode without psychotic features.
- 2\. 18-75 years of age and able to provide legal consent. 3. Referred to Stanford ECT service by treating physician for bilateral electroconvulsive therapy with inpatient hospitalization.
- 4\. Completed process for consenting to the clinical use of ECT according to California State law.
- 5\. Females of childbearing potential must be using a double-barrier method of contraception during the study and for 30 days after the study (modified 6-2003)
Exclusion
- Subjects will be excluded from participation if they meet any of the following criteria:
- Treatment with ECT in the 6 months prior to screening.
- Meets criteria for drug or alcohol abuse or dependence in the 6 months prior to screening.
- Use of alcohol or illegal drugs within seven days of randomization or during study.
- Presence of unstable or untreated cardiovascular disease, hypertension, or endocrine disorder as determined by investigator.
- Use of antipsychotic, antidepressant, or other prescription medications unless dose is stable for at least 7 days prior to randomization.
- Use of any investigational treatment within 30 days of randomization.
- Current pregnancy.
- Current lactation.
- Previous allergic reaction to mifepristone or drugs of similar chemical structure. (added 6-2003)
- Use of any oral contraceptives or other drugs that may result in adverse drug-mifepristone interaction effects. A 30-day wash out period for oral contraceptives is required before mifepristone begins.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00285818
Start Date
January 1 2003
End Date
April 1 2009
Last Update
February 16 2017
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305