Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285818
Status:
COMPLETED
Last Update Posted:
2017-02-16
First Post:
2006-01-31
Brief Title:
Mifepristone Treatment for Patients With Non-psychotic Major Depressive Disorder Receiving Bilateral ECT
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
A Double-blind Placebo-controlled Study of Mifepristone in Patients With Non-psychotic Major Depressive Disorder Referred for Bilateral Electroconvulsive Therapy ECT
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 first ECT treatment Screening procedures will include Psychiatric interviews and ratings including MINI Hamilton Depression Rating Scale and Clinicians Global Impression and reviewretrieval 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 subjects 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 11 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 Clinicians Global Impression before their first ECT treatment
Day 11 visit 2 assessments will include psychiatric ratings including Hamilton Depression Rating Scale and Clinicians 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 Clinicians 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 Clinicians 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 participants 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 Stanfords ECT Service run every Monday Wednesday and Friday
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 Clinicians Global Impression and reviewretrieval 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 subjects 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 11 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 Clinicians Global Impression before their first ECT treatment
Day 11 visit 2 assessments will include psychiatric ratings including Hamilton Depression Rating Scale and Clinicians 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 Clinicians 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 Clinicians 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 participants 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 Stanfords ECT Service run every Monday Wednesday and Friday
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Oberndorf Family Fund | OTHER | Stanford University | None |