DepressionNCT00186056
Mifepristone in Refractory Depression
A study testing Mifepristone in people with Depression, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the study is to examine the effectiveness of mifepristone treatment in patients with refractory depression. Refractory depression is defined as clinical depression that is unimproved after treatment with at least 2 different antidepressants of adequate dose and time trial. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to May 2007
- 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
Who may be able to join
- 21-item HAM-D score of 20 or above.
- If currently taking antipsychotic, antidepressant, anticonvulsant, and/or mood-stabilizing medications, must be stable on the medication for at least three weeks prior to entering the study.
- At least 2 failed antidepressant medication trials of adequate dose and duration.
- Between 18 and 75 years of age.
- Not currently pregnant or trying to become pregnant. Exclusion Criteria:-History of schizophrenia or other psychotic disorders.
- Transcranial magnetic stimulation treatment or ECT in the 3 months prior to starting the study.
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- History of vagus nerve stimulation treatment.
- No unstable or untreated cardiovascular disease, hypertension, or endocrine disorder.
- Current use of oral contraceptives or any other drug that may result in adverse drug-mifepristone interactions effects (including Amiodarone, Clarithromycin, Erythromycin, Fluconazole, Fluvoxamine, Indinavir, Intraconazole, Ketoconazole, Metronidazole, Miconazole, Nefazodone, Nelfinavir, Norfloxacin, Omeprazole, Quinine, Ritonavir, Saquinavir, Troleandomycin, Zafirlukast, Carbamazepine, Dexamethasone, Ethosuximide, Phenobarbital, Phenytoin, Primidone, Rifabutin, Rifampin, Troglitazone). A 30-day wash-out period for oral contraceptives is required before mifepristone begins.
- Previous allergic reaction to mifepristone or drugs of similar chemical structure.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
The purpose of the study is to examine the effectiveness of mifepristone treatment in patients with refractory depression. Refractory depression is defined as clinical depression that is unimproved after treatment with at least 2 different antidepressants of adequate dose and time trial. Mifepristone will augment current medications.
Read the detailed description
Study Procedures:
This study will be a double-blind placebo-controlled 5-week trial.
Thirty patients with treatment refractory major depression will be studied over a one year period. Patients will be screened for eligibility, no more than two weeks prior to enrollment, which will involve psychiatric interviews (including the SCID-Mini, HAM-D, BPRS, and CGI-S), a physical exam, and blood and urine analyses.
Clinical laboratory assessments include a serum pregnancy test (for all females), comprehensive blood count, comprehensive metabolic panel, lipid panel, fasting insulin, glucose tolerance test, urine toxicology, and electrocardiogram.
If subjects are found to be eligible, they will be asked return within two weeks of their eligibility screening visit to begin the study. Additionally, they will be asked to keep a diary of their sleep pattern for 1 week prior to entering the study and for the entire 5 week duration of the study.
On the day before beginning study medication (Study Day 0), patients will be administered the HAM-D, BPRS, CGI-S, CGI-I and neuropsychological tests, and vitals will be obtained. Patients will also undergo an afternoon blood draw, with a blood sample taken each hour beginning at 1:00PM and ending at 4:00PM, in order to assess baseline cortisol levels. Patients will then be given a 4-day supply of double-blind study medication (either 24 100mg mifepristone tablets or 24 placebo tablets) with instructions to self-administer 6 tablets each morning.
Patients will return on Day 4 to have study staff check on medication adherence, take vitals, and assess any possible adverse events. Patients will then receive an additional 3-day supply of double-blind study medication (either 18 100mg mifepristone tablets or 18 placebo tablets with instructions to orally self-administer 3 tablets each morning.
Patients will return on Day 7 to have study staff check on medication adherence, take vitals, and assess any possible adverse events. Patients will also repeat clinical laboratory assessments (including a serum pregnancy test for all females, comprehensive blood count, comprehensive metabolic panel, lipid panel, fasting insulin, glucose tolerance test, and urinary analysis) and ECG, and repeat the afternoon blood draw from 1:00PM to 4:00PM to assess cortisol levels. They will also be administered the HAM-D, BPRS, CGI-S, and CGI-I.
Patients will return after one week (Day 14) for administration of the HAM-D, BPRS, CGI-S, CGI-I, and assessment of any possible adverse events, and vitals. Patients will also repeat the afternoon blood draw from 1:00PM to 4:00PM to assess cortisol levels.
Patients will also return on Day 28 and Day 35 for administration of the HAM-D, BPRS, CGI-S, CGI-I, and assessment of any possible adverse events, and vitals. All female patients will undergo serum pregnancy testing on Day 35. In addition, all patients will be asked turn in their sleep diary to the research staff and will receive a neuropsychological test on day 35.
During the study, patients will be monitored for adrenal insufficiency and signs of Cushingnoid effects by monitoring blood pressure, pre-treatment (eligibility) and post-treatment (Day 7) metabolic panels (including measures of glucose and potassium), and monitoring of any changes that occur during the study.
Women with child-bearing potential are required to use a double-barrier method to prevent pregnancy during the study and for 30 days after the study. The double-barrier method includes 2 of the following methods of contraception: spermicidal foam, condom diaphragm, or IUD. Women of child-bearing potential are defined as women, 18 years of age or older, who have not been diagnosed by their primary care physician or gynecologist with menopause, and who have an intact uterus. Women not of child-bearing potential are defined as women, 18 years of age or older, who are status post hysterectomy or have been diagnosed by their primary care physician or gynecologist with menopause (as clinically defined by examination and results of FSH/LH blood work).
After the study, subjects will be referred for follow-up care as needed.
Subjects will not be paid for their participation in this protocol.
- Conditions
- Depression
- Being tested
- Mifepristone, Placebo Oral Tablet
- 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
Glucocorticoid antagonist
Placebo Oral TabletDrug
Also called sugar pill
Inactive placebo tab
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone | Experimental | Patients received mifepristone for 6 days Receives: Drug: Mifepristone |
| placebo | Placebo comparator | Patients received placebo for 6 days Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale
Hamilton Depression Rating Scale. Minimum score of 0 (no depressive symptoms) to maximum of 68 (very severely depressed).
Outcome Measure is reporting a Change from Baseline in HAMD scores, i.e., scores at Day 35 minus scores at Baseline.
Measured: Baseline and Day 35 HAMD scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2003
- Primary completionMay 2007
- Study completionMay 2007
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 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
- NCT00186056
- Sponsor's protocol ID
- 78804
- Status last verified
- Feb 2017
- First submitted
- 13 Sep 2005
- Last updated
- 5 Apr 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 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mifepristone in Refractory Depression
- ClinicalTrials.gov ID
- NCT00186056
- Acronym / sponsor ID
- 78804
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 5 Apr 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 the study is to examine the effectiveness of mifepristone treatment in patients with refractory depression. Refractory depression is defined as clinical depression that is unimproved after treatment with at least 2 different antidepressants of adequate dose and time trial. Mifepristone will augment current medications.
Detailed description
Study Procedures:
This study will be a double-blind placebo-controlled 5-week trial.
Thirty patients with treatment refractory major depression will be studied over a one year period. Patients will be screened for eligibility, no more than two weeks prior to enrollment, which will involve psychiatric interviews (including the SCID-Mini, HAM-D, BPRS, and CGI-S), a physical exam, and blood and urine analyses.
Clinical laboratory assessments include a serum pregnancy test (for all females), comprehensive blood count, comprehensive metabolic panel, lipid panel, fasting insulin, glucose tolerance test, urine toxicology, and electrocardiogram.
If subjects are found to be eligible, they will be asked return within two weeks of their eligibility screening visit to begin the study. Additionally, they will be asked to keep a diary of their sleep pattern for 1 week prior to entering the study and for the entire 5 week duration of the study.
On the day before beginning study medication (Study Day 0), patients will be administered the HAM-D, BPRS, CGI-S, CGI-I and neuropsychological tests, and vitals will be obtained. Patients will also undergo an afternoon blood draw, with a blood sample taken each hour beginning at 1:00PM and ending at 4:00PM, in order to assess baseline cortisol levels. Patients will then be given a 4-day supply of double-blind study medication (either 24 100mg mifepristone tablets or 24 placebo tablets) with instructions to self-administer 6 tablets each morning.
Patients will return on Day 4 to have study staff check on medication adherence, take vitals, and assess any possible adverse events. Patients will then receive an additional 3-day supply of double-blind study medication (either 18 100mg mifepristone tablets or 18 placebo tablets with instructions to orally self-administer 3 tablets each morning.
Patients will return on Day 7 to have study staff check on medication adherence, take vitals, and assess any possible adverse events. Patients will also repeat clinical laboratory assessments (including a serum pregnancy test for all females, comprehensive blood count, comprehensive metabolic panel, lipid panel, fasting insulin, glucose tolerance test, and urinary analysis) and ECG, and repeat the afternoon blood draw from 1:00PM to 4:00PM to assess cortisol levels. They will also be administered the HAM-D, BPRS, CGI-S, and CGI-I.
Patients will return after one week (Day 14) for administration of the HAM-D, BPRS, CGI-S, CGI-I, and assessment of any possible adverse events, and vitals. Patients will also repeat the afternoon blood draw from 1:00PM to 4:00PM to assess cortisol levels.
Patients will also return on Day 28 and Day 35 for administration of the HAM-D, BPRS, CGI-S, CGI-I, and assessment of any possible adverse events, and vitals. All female patients will undergo serum pregnancy testing on Day 35. In addition, all patients will be asked turn in their sleep diary to the research staff and will receive a neuropsychological test on day 35.
During the study, patients will be monitored for adrenal insufficiency and signs of Cushingnoid effects by monitoring blood pressure, pre-treatment (eligibility) and post-treatment (Day 7) metabolic panels (including measures of glucose and potassium), and monitoring of any changes that occur during the study.
Women with child-bearing potential are required to use a double-barrier method to prevent pregnancy during the study and for 30 days after the study. The double-barrier method includes 2 of the following methods of contraception: spermicidal foam, condom diaphragm, or IUD. Women of child-bearing potential are defined as women, 18 years of age or older, who have not been diagnosed by their primary care physician or gynecologist with menopause, and who have an intact uterus. Women not of child-bearing potential are defined as women, 18 years of age or older, who are status post hysterectomy or have been diagnosed by their primary care physician or gynecologist with menopause (as clinically defined by examination and results of FSH/LH blood work).
After the study, subjects will be referred for follow-up care as needed.
Subjects will not be paid for their participation in this protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mifepristone | Experimental | Drug: MifepristonePatients received mifepristone for 6 days |
| placebo | Placebo comparator | Drug: Placebo Oral TabletPatients received placebo for 6 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 21-item HAM-D score of 20 or above.
- If currently taking antipsychotic, antidepressant, anticonvulsant, and/or mood-stabilizing medications, must be stable on the medication for at least three weeks prior to entering the study.
- At least 2 failed antidepressant medication trials of adequate dose and duration.
- Between 18 and 75 years of age.
- Not currently pregnant or trying to become pregnant. Exclusion Criteria:-History of schizophrenia or other psychotic disorders.
Key exclusion criteria (0 listed)
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 486Glucocorticoid antagonist | Drug | Mifepristone |
| Placebo Oral TabletAlso: sugar pillInactive placebo tab | Drug | placebo |
Primary outcome
Hamilton Depression Rating Scale
Time frame: Baseline and Day 35 HAMD scores
Hamilton Depression Rating Scale. Minimum score of 0 (no depressive symptoms) to maximum of 68 (very severely depressed). Outcome Measure is reporting a Change from Baseline in HAMD scores, i.e., scores at Day 35 minus scores at Baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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?
The sponsor lists 10 inclusion and 0 exclusion criteria. 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 5 Apr 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 5 Apr 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 (time frame: Baseline and Day 35 HAMD scores). 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 5 Apr 2017.