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

NCT00285818 | Completed Results

• 2 other identifiers: 2HSE450Oberndorf Family Fund
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale Score

  The Hamilton Depression Scale measures the severity of depression. There are 17 items rated 0 to 4. A total score of 0 indicates that the patient does not endorse any symptoms of depression. The maximum score (the most severe depression) is 68. The outcome measure is the difference between Visit 1 and Visit 4 Hamilton Depression Rating Scale scores of the mifepristone and placebo groups.

  Screening to Final Visit

Study Arms (2)

Mifepristone

ACTIVE COMPARATOR

Patients receive mifepristone one day before and for 5 additional days after starting ECT

Drug: Mifepristone

Placebo Oral Capsule

PLACEBO COMPARATOR

Patients receive a placebo capsule one day before and for 5 additional days after starting ECT

Drug: Placebo Oral Capsule

Interventions

Mifepristone DRUG

Mifepristone is a glucocorticoid receptor antagonist.

Also known as: RU-486

Mifepristone

Placebo Oral Capsule DRUG

Placebo is a capsule without a pharmacological active ingredient

Also known as: Sugar pill

Placebo Oral Capsule

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Meets DSM-IV criteria for Major Depressive Episode without psychotic features.
• \. 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.
• \. Completed process for consenting to the clinical use of ECT according to California State law.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Mifepristone; Sugars

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Dr. Hugh Brent Solvason
• Organization: Stanford University

solvason@stanford.edu

650 776 4793

Study Officials

• Hugh Brent Solvason

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 31, 2006
• First Posted: February 2, 2006
• Study Start: January 1, 2003
• Primary Completion: January 1, 2009
• Study Completion: April 1, 2009
• Last Updated: February 16, 2017
• Results First Posted: February 16, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)