Depression Clinical Trial
Official title:
A Double-blind, Placebo-controlled Study of Mifepristone in Patients With Non-psychotic Major Depressive Disorder Referred for Bilateral Electroconvulsive Therapy (ECT)
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.
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 first ECT
treatment. Screening procedures will include: Psychiatric interviews and ratings (including
MINI, Hamilton Depression Rating Scale and Clinician's Global Impression) and
review/retrieval of results of pre-ECT physical exam, ECG, chest x-ray, laboratory
evaluations (including comprehensive metabolic panel, comprehensive blood count, and urine
toxicology), and vital signs from the subject's medical record. A urine pregnancy test will
be included for females of childbearing potential. Concomitant medications and pre-existing
health issues will be recorded. Subjects who are deemed eligible for this study will then
undergo a battery of neuropsychiatric assessments and will be admitted to GCRC for
collection of blood samples to measure adrenocorticotropin (ACTH) and cortisol levels. These
samples will be collected hourly beginning at 1pm and ending at 4pm.
Day 1: Subjects will be randomized 1:1 to receive either mifepristone 600mg or placebo each
day at bedtime beginning two days prior to the first ECT treatment. Subjects will be
administered study medication on Day 1 through Day 8.
Day 3: Subjects will be interviewed with the Hamilton Depression Rating Scale and
Clinician's Global Impression before their first ECT treatment.
Day 11: (visit 2) assessments will include psychiatric ratings (including Hamilton
Depression Rating Scale and Clinician's Global Impression) and a battery of neuropsychiatric
assessments. Adverse events and concomitant medications will be reviewed and recorded.
Subjects will be admitted to the GCRC for collection of blood samples to measure ACTH and
cortisol levels. Samples will be collected hourly beginning at 1pm and ending at 4pm.
Day 18: (visit 3) assessments will include psychiatric ratings (including Hamilton
Depression Rating Scale and Clinician's Global Impression). Adverse events and concomitant
medications will be reviewed and recorded. Clinical laboratory assessments will be completed
(including a urine pregnancy test for females, comprehensive metabolic panel, comprehensive
blood count, urine toxicology, and ECG.) Final visit: (visit 4) will occur 24-72 hours after
the last ECT treatment. Assessments will include psychiatric ratings (including Hamilton
Depression Rating Scale and Clinician's Global Impression) and a battery of neuropsychiatric
assessments. Adverse events and concomitant medications will be reviewed and recorded. A
urine pregnancy test will be completed for females.
In addition to the ECT treatment consent, the following materials will be collected from the
participant's medical record for every ECT treatment: ECT treatment orders, ECT procedure
note and the results of each pre-ECT Montgomery-Asberg Depression Rating Scale (MADRS). ECT
treatments at Stanford's ECT Service run every Monday, Wednesday and Friday.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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