Major Depressive DisorderPhase 3NCT00128479

A United States Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression

A Phase 3 study testing mifepristone, mifepristone 600 mg and mifepristone 1200 mg in people with Major Depressive Disorder and Psychotic Disorders, run by Corcept Therapeutics at 44 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Major Depressive Disorder, Psychotic Disorders
What is being tested?: mifepristone, mifepristone 600 mg and mifepristone 1200 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 443 participants
Where: 44 sitesUnited States
Study dates: Sep 2004to Jan 2007
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

44 sites in 1 country.

City, postcode or hospital

44 sites in 1 country

United States44 sites

Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87102
Brooklyn Medical Institute
Brooklyn, New York, 11223
Center for Emotional Fitness
Cerritos, California, 90703
Segal Institute
Charleston, South Carolina, 29405
Lutheran Hospital
Cleveland, Ohio, 44109
UT Southwestern Medical Center
Dallas, Texas, 75235
The Cedars Hospital, InSite Clinical Research
DeSoto, Texas, 75115
Advanced Bio-Behavioral Science, Inc
Elmsford, New York, 10523
Professional Clinical Research Inc.
Fort Lauderdale, Florida, 33319
Harbor Medical Associates, Inc.
Fountain Valley, California, 92708
Geriatric and Adult Psych
Hamden, Connecticut, 06518
Hawaii Clinical Research Center
Honolulu, Hawaii, 96826
Felin-Jennings Clinic
Houston, Texas, 77074
Amit Vijapura, MD
Jacksonville, Florida, 32256
Harmony Research
Johnson City, Tennessee, 37601
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70601
R&D Clinical Research, Inc.
Lake Jackson, Texas, 77566
K&S Research Services
Little Rock, Arkansas, 72201
Tukoi Inst for Clinical Research
Miami, Florida, 33180
Southwest Cleveland Sleep Center, Inc.
Middleburg Heights, Ohio, 44130
Crossroads Counseling & Consulting Associates
Moon Township, Pennsylvania, 15108
Synergy Clinical Research Center
National City, California, 91950
Louisiana Research Associates, Inc
New Orleans, Louisiana, 70114
Bioquan Research Group, Inc.
North Miami, Florida, 33161
Scientific Clinical Research, Inc.
North Miami, Florida, 33161
Midwest Center for Neurobehavioral Medicine
Oakbrook Terrace, Illinois, 60181
Excell Research
Oceanside, California, 92056
IPS Research Company
Oklahoma City, Oklahoma, 73101
CNS Research Institute (CRI)
Philadelphia, Pennsylvania, 19149
CTT Research
Prairie Village, Kansas, 66206
Pacific Clinical Research Medical Group
Riverside, California, 92506
Saaid Khojasteh & Assoc, Inc
Saint Charles, Missouri, 63301
Peryam and Kroll Health Care Research
Schaumburg, Illinois, 60194
America's Doctor/Essential Doctor, Inc
Seattle, Washington, 98126
Mark Ashby, MD
Sebring, Florida, 33870
LSU Health Sciences Center
Shreveport, Louisiana, 71103
Clintell, Inc.
Skokie, Illinois, 60077
Medex Healthcare Research
St Louis, Missouri, 63108
Saint Vincent Catholic Medical Centers of New York
Staten Island, New York, 10304
Stedman Clinical Trials, LLC
Tampa, Florida, 33613
Anxiety and Depression Clinic at Montefiore Medical Center
The Bronx, New York, 10467
AV Institute, Inc.
Torrance, California, 90505
Comprehensive NeuroScience, Inc.
Washington D.C., District of Columbia, 20016
Neuropsychiatric Institute of Orange County
Westminster, California, 92683

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety and Efficacy of Three Dose Levels of CORLUX™ (Mifepristone) Plus an Antidepressant vs. Placebo Plus an Antidepressant in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features (PMD)

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, mifepristone matched placebo, mifepristone 600 mg, mifepristone 1200 mg
Keywords: PMD, Psychotic Depression, Psychosis, Major Depression, Depression, Psychotic Major Depression
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
mifepristone 300 mg daily for 7 dats
mifepristone matched placeboDrug
daily for 7 days
mifepristone 600 mgDrug
mifepristone 600 mg daily for 7 days
mifepristone 1200 mgDrug
mifepristone 1200 mg daily for 7 days

Study groups in NCT00128479
Study group	Role	What they receive
mifepristone 300 mg	Experimental	Not described Receives: Drug: mifepristone
placebo	Placebo comparator	Not described Receives: Drug: mifepristone matched placebo
mifepristone 600 mg	Experimental	Not described Receives: Drug: mifepristone 600 mg
mifepristone 1200 mg	Experimental	Not described Receives: Drug: mifepristone 1200 mg

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: screen, Days 0, 7, 14, 28, 42, 56

Secondary outcomes (1)

The change in a measure of depression
Measured: screen, Days 0,7, 14, 28, 42, 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2004Jan 2007

First posted10 Aug 2005 (estimated)
Study startSep 2004
Primary completionJan 2007
Study completionJan 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)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: 443 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00128479
Sponsor's protocol ID: C-1073-06
Status last verified: Feb 2012
First submitted: 8 Aug 2005
Last updated: 15 Feb 2012
Results posted: No
Data monitoring committee: No

Publications

Brogden 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 7682909
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 12242054
Belanoff 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 11593077
Kruizinga J, Liemburg E, Burger H, Cipriani A, Geddes J, Robertson L, Vogelaar B, Nolen WA. Pharmacological treatment for psychotic depression. Cochrane Database Syst Rev. 2021 Dec 7;12(12):CD004044. doi: 10.1002/14651858.CD004044.pub5.
PubMed 34875106
Block 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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, Parallel Group Study of the Safety and Efficacy of Three Dose Levels of CORLUX™ (Mifepristone) Plus an Antidepressant vs. Placebo Plus an Antidepressant in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features (PMD)
ClinicalTrials.gov ID: NCT00128479
Acronym / sponsor ID: C-1073-06
Conditions: Major Depressive Disorder, Psychotic Disorders
Keywords: PMD, Psychotic Depression, Psychosis, Major Depression, Depression, Psychotic Major Depression
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 443 participants (actual)
Lead sponsor: Corcept TherapeuticsIndustry (pharma, biotech, devices)
Study start: Sep 2004
Primary completion: Jan 2007 (actual)
Study completion: Jan 2007 (actual)
First posted: 10 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
mifepristone 300 mg	Experimental	Drug: mifepristone
placebo	Placebo comparator	Drug: mifepristone matched placebo
mifepristone 600 mg	Experimental	Drug: mifepristone 600 mg
mifepristone 1200 mg	Experimental	Drug: mifepristone 1200 mg

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
mifepristonemifepristone 300 mg daily for 7 dats	Drug	mifepristone 300 mg
mifepristone matched placebodaily for 7 days	Drug	placebo
mifepristone 600 mgmifepristone 600 mg daily for 7 days	Drug	mifepristone 600 mg
mifepristone 1200 mgmifepristone 1200 mg daily for 7 days	Drug	mifepristone 1200 mg

Primary outcome

The change in a measure of psychosis
Time frame: screen, Days 0, 7, 14, 28, 42, 56

1 secondary outcome

The change in a measure of depression
Time frame: screen, Days 0,7, 14, 28, 42, 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 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.
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.
Derived from this study: PubMed 34875106Kruizinga J, Liemburg E, Burger H, Cipriani A, Geddes J, Robertson L, Vogelaar B, Nolen WA. Pharmacological treatment for psychotic depression. Cochrane Database Syst Rev. 2021 Dec 7;12(12):CD004044. doi: 10.1002/14651858.CD004044.pub5.
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

44 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 44 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: screen, Days 0, 7, 14, 28, 42, 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 NCT00128479, which also lists 5 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.