DepressionNCT00285818
Mifepristone Treatment for Patients With Non-psychotic Major Depressive Disorder Receiving Bilateral ECT
A study testing Mifepristone in people with Depression, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depression
- What is being tested?
- Mifepristone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Apr 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:To be considered for participation in the study, subject must meet all of the following criteria:
- 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.
- 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:
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Mifepristone, Placebo Oral Capsule
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Also called RU-486
Mifepristone is a glucocorticoid receptor antagonist.
Placebo Oral CapsuleDrug
Also called Sugar pill
Placebo is a capsule without a pharmacological active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone | Active comparator | Patients receive mifepristone one day before and for 5 additional days after starting ECT Receives: Drug: Mifepristone |
| Placebo Oral Capsule | Placebo comparator | Patients receive a placebo capsule one day before and for 5 additional days after starting ECT Receives: Drug: Placebo Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening to Final Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2006 (estimated)
- Study startJan 2003
- Primary completionJan 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hugh Brent Solvason, Stanford University
- Investigators
- Hugh Brent Solvason, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285818
- Sponsor's protocol ID
- 2HSE450
- Other IDs
- Oberndorf Family Fund
- Status last verified
- Dec 2016
- First submitted
- 31 Jan 2006
- Last updated
- 16 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled Study of Mifepristone in Patients With Non-psychotic Major Depressive Disorder Referred for Bilateral Electroconvulsive Therapy (ECT)
- ClinicalTrials.gov ID
- NCT00285818
- Acronym / sponsor ID
- 2HSE450
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jan 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 2 Feb 2006 (estimated)
- Results
- Posted 16 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mifepristone | Active comparator | Drug: MifepristonePatients receive mifepristone one day before and for 5 additional days after starting ECT |
| Placebo Oral Capsule | Placebo comparator | Drug: Placebo Oral CapsulePatients receive a placebo capsule one day before and for 5 additional days after starting ECT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MifepristoneAlso: RU-486Mifepristone is a glucocorticoid receptor antagonist. | Drug | Mifepristone |
| Placebo Oral CapsuleAlso: Sugar pillPlacebo is a capsule without a pharmacological active ingredient | Drug | Placebo Oral Capsule |
Primary outcome
Hamilton Depression Rating Scale Score
Time frame: Screening to Final Visit
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugh Brent Solvason principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mifepristone in people with Depression, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale Score (time frame: Screening to Final Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2017.