Major Depressive DisorderPhase 3NCT00130676
A United States Study of Corlux for Psychotic Symptoms in Psychotic Major Depression
A Phase 3 study testing Mifepristone in people with Major Depressive Disorder and Psychotic Disorders, run by Corcept Therapeutics at 23 sites in United States.
Trial summary
Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called cortisol. Under normal conditions, cortisol and other hormones are created by the body in response to physical and emotional stress, triggering a healthy stress response. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder, Psychotic Disorders
- What is being tested?
- Mifepristone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 257 participants
- Where
- 23 sitesUnited States
- Study dates
- Sep 2004to Jun 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Individuals eligible for enrollment into this study are male and female adult patients who:
- Are 18 to 75 years of age
- Have a diagnosis of major depressive disorder with psychotic features (DSM-IV 296.24 or 296.34)
- Are able to provide written informed consent
Who cannot join
- Individuals not eligible to be enrolled into the study are those who:
- Have a major medical problem
- Have previously participated in a Corlux (C-1073, mifepristone) clinical trial
- Have a history of an allergic reaction to Corlux (C-1073, mifepristone)
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
Claghorn-Lesem Research Clinic
Bellaire, Texas, 77401
Northwest Clinical Research Center
Bellevue, Washington, 98004
CNS Research Institute
Clementon, New Jersey, 08021
Midwest Clinical Research Center
Dayton, Ohio, 45408
Psychopharmacology Research
Farmington Hills, Michigan, 48334
Zucker Hillside Hospital
Glen Oaks, New York, 11004
Valle Vista Health System
Greenwood, Indiana, 46143
University of Florida Clinical Trials
Jacksonville, Florida, 32257
Robert Horne, MD
Las Vegas, Nevada, 89102
Neurobehavioral Research Company
Lawrence, New York, 11559
Rakesh Ranjan, MD and Associates, Inc
Lyndhurst, Ohio, 44124
NMDNJ
Newark, New Jersey, 07101
American Medical Research, Inc.
Oak Brook, Illinois, 60523
IPS Research Company
Oklahoma City, Oklahoma, 73101
CNS Research Institute
Philadelphia, Pennsylvania, 19149
CNRI-LA
Pico Rivera, California, 90660
Quantum Laboratories/Memory Disorder Center
Pompano Beach, Florida, 33064
International Clinical Research Associates
Richmond, Virginia, 23229
Behavioral Health 2000, LLC
Riverside, California, 92506
Cnri, Llc
San Diego, California, 92126
Bio Behavioral Health
Toms River, New Jersey, 08755
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of CORLUX™ (Mifepristone) in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features
Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called cortisol. Under normal conditions, cortisol and other hormones are created by the body in response to physical and emotional stress, triggering a healthy stress response. People who suffer from psychotic major depression may have unusually high levels of cortisol circulating within them or abnormal patterns of cortisol levels, overloading the stress response mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If Corlux can keep the body's cortisol receptors from being overloaded, the stress response system may return to normal function, which may result in improvement of symptoms. The purpose of this 56 day study is to learn the safety and effectiveness of Corlux in patients who have been diagnosed with psychotic major depression (PMD).
- Conditions
- Major Depressive Disorder, Psychotic Disorders
- Being tested
- Mifepristone, matching placebo
- Keywords
- PMD, Psychotic Major Depression, Depression, Major Depression, Psychosis
- Medical subject headings
- Depressive Disorder, Major, Psychotic Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
daily for 7 days
matching placeboDrug
daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| mifepristone 600 mg | Experimental | Not described Receives: Drug: Mifepristone |
| matching placebo | Placebo comparator | Not described Receives: Drug: matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in a measure of psychosis
Measured: screening and on Days 0, 7, 14, 28, 42, and 56
Secondary outcomes (1)
The change in a measure of depression
Measured: screening and on Days 0, 7, 14, 28, 42, and 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2005 (estimated)
- Study startSep 2004
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katherine Beebe, PhD, Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130676
- Sponsor's protocol ID
- C-1073-07
- Status last verified
- Feb 2012
- First submitted
- 12 Aug 2005
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Belanoff JK, Rothschild AJ, Cassidy F, DeBattista C, Baulieu EE, Schold C, Schatzberg AF. An open label trial of C-1073 (mifepristone) for psychotic major depression. Biol Psychiatry. 2002 Sep 1;52(5):386-92. doi: 10.1016/s0006-3223(02)01432-4.
PubMed 12242054Belanoff JK, Flores BH, Kalezhan M, Sund B, Schatzberg AF. Rapid reversal of psychotic depression using mifepristone. J Clin Psychopharmacol. 2001 Oct;21(5):516-21. doi: 10.1097/00004714-200110000-00009.
PubMed 11593077Brogden RN, Goa KL, Faulds D. Mifepristone. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential. Drugs. 1993 Mar;45(3):384-409. doi: 10.2165/00003495-199345030-00007.
PubMed 7682909Block TS, Kushner H, Kalin N, Nelson C, Belanoff J, Schatzberg A. Combined Analysis of Mifepristone for Psychotic Depression: Plasma Levels Associated With Clinical Response. Biol Psychiatry. 2018 Jul 1;84(1):46-54. doi: 10.1016/j.biopsych.2018.01.008. Epub 2018 Jan 31.
PubMed 29523415
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of CORLUX™ (Mifepristone) in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features
- ClinicalTrials.gov ID
- NCT00130676
- Acronym / sponsor ID
- C-1073-07
- Conditions
- Major Depressive Disorder, Psychotic Disorders
- Keywords
- PMD, Psychotic Major Depression, Depression, Major Depression, Psychosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 16 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called cortisol. Under normal conditions, cortisol and other hormones are created by the body in response to physical and emotional stress, triggering a healthy stress response. People who suffer from psychotic major depression may have unusually high levels of cortisol circulating within them or abnormal patterns of cortisol levels, overloading the stress response mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If Corlux can keep the body's cortisol receptors from being overloaded, the stress response system may return to normal function, which may result in improvement of symptoms. The purpose of this 56 day study is to learn the safety and effectiveness of Corlux in patients who have been diagnosed with psychotic major depression (PMD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mifepristone 600 mg | Experimental | Drug: Mifepristone |
| matching placebo | Placebo comparator | Drug: matching placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals eligible for enrollment into this study are male and female adult patients who:
- Are 18 to 75 years of age
- Have a diagnosis of major depressive disorder with psychotic features (DSM-IV 296.24 or 296.34)
- Are able to provide written informed consent
Key exclusion criteria (4 listed)
- Have a major medical problem
- Have previously participated in a Corlux (C-1073, mifepristone) clinical trial
- Have a history of an allergic reaction to Corlux (C-1073, mifepristone)
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 |
|---|---|---|
| Mifepristonedaily for 7 days | Drug | mifepristone 600 mg |
| matching placebodaily for 7 days | Drug | matching placebo |
Primary outcome
The change in a measure of psychosis
Time frame: screening and on Days 0, 7, 14, 28, 42, and 56
1 secondary outcome
The change in a measure of depression
Time frame: screening and on Days 0, 7, 14, 28, 42, and 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2012.
- Background: PubMed 12242054Belanoff JK, Rothschild AJ, Cassidy F, DeBattista C, Baulieu EE, Schold C, Schatzberg AF. An open label trial of C-1073 (mifepristone) for psychotic major depression. Biol Psychiatry. 2002 Sep 1;52(5):386-92. doi: 10.1016/s0006-3223(02)01432-4.
- Background: PubMed 11593077Belanoff JK, Flores BH, Kalezhan M, Sund B, Schatzberg AF. Rapid reversal of psychotic depression using mifepristone. J Clin Psychopharmacol. 2001 Oct;21(5):516-21. doi: 10.1097/00004714-200110000-00009.
- Background: PubMed 7682909Brogden RN, Goa KL, Faulds D. Mifepristone. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential. Drugs. 1993 Mar;45(3):384-409. doi: 10.2165/00003495-199345030-00007.
- Derived from this study: PubMed 29523415Block TS, Kushner H, Kalin N, Nelson C, Belanoff J, Schatzberg A. Combined Analysis of Mifepristone for Psychotic Depression: Plasma Levels Associated With Clinical Response. Biol Psychiatry. 2018 Jul 1;84(1):46-54. doi: 10.1016/j.biopsych.2018.01.008. Epub 2018 Jan 31.
- Corcept TherapeuticsLink provided by the sponsor.
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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.
Katherine Beebe, PhD study director
Corcept Therapeutics
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mifepristone in people with Major Depressive Disorder and Psychotic Disorders, run by Corcept Therapeutics at 23 sites 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 4 inclusion and 4 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 15 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change in a measure of psychosis (time frame: screening and on Days 0, 7, 14, 28, 42, and 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00130676, which also lists 4 linked publications.
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 15 Feb 2012.