Mifepristone Treatment for Patients With Non-psychotic Major Depressive Disorder Receiving Bilateral ECT

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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 protecting cognitive function during ECT. Both Mifepristone and ECT appear to normalize hyperfunctioning of the hypothalmic-pituitary-adrenal (HPA) axis, which has been found among patients with major depression referred for ECT. The combination of these two treatments in major depression may lead to a more rapid clinical response than ECT alone. Additionally, there appears to be a connection between pre-ECT higher cortisol levels due to HPA axis hyperfunctioning and post-ECT cognitive impairment. Administration of mifepristone prior to and during ECT treatment may reduce cortisol levels and reduce the incidence of cognitive impairment observed after ECT.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: National Institutes of Health (NIH)
• Treatments: Mifepristone

Criteria

Inclusion Criteria: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 Criteria:Subjects will be excluded from participation if they meet any of the following criteria:

1. Treatment with ECT in the 6 months prior to screening.

2. Meets criteria for drug or alcohol abuse or dependence in the 6 months prior to screening.

3. Use of alcohol or illegal drugs within seven days of randomization or during study.

4. Presence of unstable or untreated cardiovascular disease, hypertension, or endocrine disorder as determined by investigator.

5. Use of antipsychotic, antidepressant, or other prescription medications unless dose is stable for at least 7 days prior to randomization.

6. Use of any investigational treatment within 30 days of randomization.

7. Current pregnancy.

8. Current lactation.

9. Previous allergic reaction to mifepristone or drugs of similar chemical structure. (added 6-2003)

10. 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.