Mifepristone Used to Treat Patients With Non-psychotic Major Depressive Disorder Referred for Bilateral Electroconvulsive Therapy (ECT)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00285818
First received: January 31, 2006
Last updated: September 15, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention
Depression
Drug: Mifepristone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Study of Mifepristone in Patients With Non-psychotic Major Depressive Disorder Referred for Bilateral Electroconvulsive Therapy (ECT)

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale [ Time Frame: Screening to Final Visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neuropsychiatric Assessments [ Time Frame: Time 1 versus post ECT time points ] [ Designated as safety issue: No ]
  • Does mifepristone act as a protective agent to cognitive function as measured by the difference in neuropsychiatric assessments between placebo and mifepristone groups [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2003
Study Completion Date: April 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285818

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Hugh Brent Solvason Stanford University
  More Information

No publications provided

Responsible Party: Hugh Brent Solvason, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00285818     History of Changes
Other Study ID Numbers: 2HSE450, 12062
Study First Received: January 31, 2006
Last Updated: September 15, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Mifepristone
Abortifacient Agents
Abortifacient Agents, Steroidal
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital
Contraceptives, Postcoital, Synthetic
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014