Psychotic DepressionPhase 3NCT00637494
A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features
A Phase 3 study testing mifepristone in people with Psychotic Depression and Severe Major Depression With Psychotic Features, run by Corcept Therapeutics at 42 sites in United States.
Trial summary
Approximately 450 patients will be randomized to receive mifepristone or placebo for 7 days followed by antidepressant. The purpose is to compare the efficacy of mifepristone followed by antidepressant versus placebo followed by antidepressant in reducing psychotic symptoms in patients with a diagnosis of psychotic… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Psychotic Depression, Severe Major Depression With Psychotic Features, Psychosis
- 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
- 292 participants
- Where
- 42 sitesUnited States
- Study dates
- Mar 2008to Jun 2014
- Phase
- Phase 3
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have provided written consent to participate in the study prior to any study procedures and understand that they are free to withdraw from the study at any time. Patients must be able to read and understand the consent form, complete study-related procedures, and communicate with the study staff
- Have a DSM-IV TR diagnosis of Major Depressive Disorder with Psychotic Features (DSM-IV 296.24 or 296.34), and are clinically symptomatic with their illness
- Have pre-specified minimum scores on standardized psychiatric rating scales at baseline
- Have not been taking excluded medication for at least 7 days prior to randomization
- Have a negative pregnancy test
- If not postmenopausal for ≥ 2 years or surgically sterile (6 months post-surgery), must consent (patient or partner) to utilize two medically acceptable methods of contraception, one of which is a barrier method, throughout the entire study period and for 3 months after the study is completed
Who cannot join
- Have any primary psychiatric diagnosis other than psychotic depression.
- Have a major medical problem, which in the opinion of the investigator would place the patient at undue risk.
- Have undergone electroconvulsive therapy within 3 months prior to randomization
- Have had a hospitalization due to a suicide attempt within 45 days prior to randomization
- Are female and of childbearing age, and are unable or unwilling to use two medically acceptable methods of contraception during the study and for three months after study completion, one of which must be a barrier method
- Are female and are pregnant or lactating
Show all 15Show fewer
- Are currently taking excluded medications
- Have used drugs of abuse within 30 days prior to screen, as per patient report and urine drug screen
- Have a history of active drug or alcohol abuse within 3 months or dependence within 6 months prior to screening
- Are in the opinion of the investigator at immediate risk of suicide, or at risk of harming others
- Have received investigational therapy (drug, vaccine, biological agent or device) within 6 months prior to randomization
- Have previously participated in a clinical trial of mifepristone
- Have a history of an allergic reaction to mifepristone
- Are in the investigator's opinion not appropriate for participation in the study or may not be capable of following the study schedule for any reason
- Are patients who are employees of the study unit or their family members, students who are working in the study unit, or family members of the investigator or Corcept Therapeutics
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104
South Coast Clinical Trials, Inc
Anaheim, California, 92804
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
FutureSearch Clinical Trials, L.P.
Austin, Texas, 78731
Professional Clinical Research, Inc.
Aventura, Florida, 33180
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
Carolina Clinical Trials, Inc.
Charleston, South Carolina, 29405
Millennium Psychiatric Associate
Creve Coeur, Missouri, 63141
Pillar Clinical Research, LLC
Dallas, Texas, 75243
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Midwest Clinical Research Center
Dayton, Ohio, 45417
InSite Clinical Research, LLC
DeSoto, Texas, 75115
Diligent Clinical Trials
Downey, California, 90241
Synergy Clinical Research Center
Escondido, California, 92025
Precise Research Centers
Flowood, Mississippi, 39232
University of Florida
Gainesville, Florida, 32606
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845
The Zucker Hillside Hospital
Glen Oaks, New York, 11004
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169
Segal Institute for Clinical Research
Hollywood, Florida, 33021
Inquest Clinical Group/ Global Research Associates
Hope Mills, North Carolina, 28348
Claghorn-Lesem Research Clinic
Houston, Texas, 77008
Clinical Trial Network
Houston, Texas, 77074
Fein-Jennings Clinic, Inc.
Houston, Texas, 77074
Accurate Clinical Trials
Kissimmee, Florida, 34741
K&S Professional Research Services, LLC
Little Rock, Arkansas, 72201
Woodland International Research Group, Inc.
Little Rock, Arkansas, 72211
CRI Lifetree
Marlton, New Jersey, 08053
AMB Research Center
Miami, Florida, 33144
Pacific Research Partners
Oakland, California, 94612
North County Clinical Research
Oceanside, California, 92056
Oklahoma Clinical Research Center
Oklahoma City, Oklahoma, 73112
Lakeside Behavioral Health
Orlando, Florida, 32810
Belmont Center for Comprehensive Treatment
Philadelphia, Pennsylvania, 19131
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15213
Lifetree Clinical Research
Salt Lake City, Utah, 84106
Breakthrough Clinical Trials
San Bernardino, California, 92408
Sharp Mesa Vista Hospital
San Diego, California, 92123
Cnri, Llc
San Diego, California, 92126
PsychCare Consultants Research
St Louis, Missouri, 63128
University of South Florida Dept of Psychiatry and Neurosciences
Tampa, Florida, 33613
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Mifepristone vs. Placebo in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features
Approximately 450 patients will be randomized to receive mifepristone or placebo for 7 days followed by antidepressant. The purpose is to compare the efficacy of mifepristone followed by antidepressant versus placebo followed by antidepressant in reducing psychotic symptoms in patients with a diagnosis of psychotic depression.
Read the detailed description
Up to 450 patients with psychotic depression will be randomly assigned to receive either mifepristone or matching placebo. Patients will be assessed by the investigator or site staff during screening and on study days. A single antidepressant selected from a list of approved drugs will be administered after the administration of investigational drug. Adverse events, laboratory assessments, electrocardiograms, and physical examinations will be used to assess safety.
- Being tested
- mifepristone, placebo
- Keywords
- psychotic depression, major depression with psychotic features, psychosis
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mifepristoneDrug
Also called Korlym
1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days
placeboDrug
Also called control
Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Mifepristone followed by an antidepressant Receives: Drug: mifepristone |
| 2 | Placebo comparator | Placebo followed by an antidepressant Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Mifepristone vs. Placebo Treated Patients With at Least a 50% Reduction From Baseline in Brief Psychiatric Rating Scale-Positive Symptom Subscale (BPRS-PSS) at Days 7 and 56
Response as measured by 50% reduction in psychosis at Days 7 and 56 was compared between the group administered placebo and the group administered mifepristone
Measured: 56 days
Secondary outcomes (1)
Proportion of Mifepristone Treated Patients With Plasma Drug Concentrations Equal to or Above 1637 ng/mL vs. Placebo Treated Patients Who Achieve a ≤ 50% Reduction in BPRS-PSS at Days 7 and 56
Response as measured by 50% reduction in psychosis at Days 7 and 56 was compared between the group administered placebo and the group who achieved a sufficiently high plasma level of mifepristone
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: DRC recommended stopping study as it had missed its primary endpoint
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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Psychotic DepressionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thaddeus Block, MD, Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637494
- Sponsor's protocol ID
- C-1073-14
- Status last verified
- May 2017
- First submitted
- 11 Mar 2008
- Last updated
- 5 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
DeBattista C, Belanoff J, Glass S, Khan A, Horne RL, Blasey C, Carpenter LL, Alva G. Mifepristone versus placebo in the treatment of psychosis in patients with psychotic major depression. Biol Psychiatry. 2006 Dec 15;60(12):1343-9. doi: 10.1016/j.biopsych.2006.05.034. Epub 2006 Aug 4.
PubMed 16889757Flores BH, Kenna H, Keller J, Solvason HB, Schatzberg AF. Clinical and biological effects of mifepristone treatment for psychotic depression. Neuropsychopharmacology. 2006 Mar;31(3):628-36. doi: 10.1038/sj.npp.1300884.
PubMed 16160710Belanoff 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 11593077Block 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 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Mifepristone vs. Placebo in the Treatment of Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features
- ClinicalTrials.gov ID
- NCT00637494
- Acronym / sponsor ID
- C-1073-14
- Keywords
- psychotic depression, major depression with psychotic features, psychosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DRC recommended stopping study as it had missed its primary endpoint
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 18 Mar 2008 (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.
Approximately 450 patients will be randomized to receive mifepristone or placebo for 7 days followed by antidepressant. The purpose is to compare the efficacy of mifepristone followed by antidepressant versus placebo followed by antidepressant in reducing psychotic symptoms in patients with a diagnosis of psychotic depression.
Detailed description
Up to 450 patients with psychotic depression will be randomly assigned to receive either mifepristone or matching placebo. Patients will be assessed by the investigator or site staff during screening and on study days. A single antidepressant selected from a list of approved drugs will be administered after the administration of investigational drug. Adverse events, laboratory assessments, electrocardiograms, and physical examinations will be used to assess safety.
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 |
|---|---|---|
| 1 | Active comparator | Drug: mifepristoneMifepristone followed by an antidepressant |
| 2 | Placebo comparator | Drug: placeboPlacebo followed by an antidepressant |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have provided written consent to participate in the study prior to any study procedures and understand that they are free to withdraw from the study at any time. Patients must be able to read and understand the consent form, complete study-related procedures, and communicate with the study staff
- Have a DSM-IV TR diagnosis of Major Depressive Disorder with Psychotic Features (DSM-IV 296.24 or 296.34), and are clinically symptomatic with their illness
- Have pre-specified minimum scores on standardized psychiatric rating scales at baseline
- Have not been taking excluded medication for at least 7 days prior to randomization
- Have a negative pregnancy test
Key exclusion criteria (15 listed)
- Have any primary psychiatric diagnosis other than psychotic depression.
- Have a major medical problem, which in the opinion of the investigator would place the patient at undue risk.
- Have undergone electroconvulsive therapy within 3 months prior to randomization
- Have had a hospitalization due to a suicide attempt within 45 days prior to randomization
- Are female and of childbearing age, and are unable or unwilling to use two medically acceptable methods of contraception during the study and for three months after study completion, one of which must be a barrier method
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: Korlym1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days | Drug | 1 |
| placeboAlso: controlTablets of identical appearance to active drug, once a day by mouth for the initial 7 days | Drug | 2 |
Primary outcome
Proportion of Mifepristone vs. Placebo Treated Patients With at Least a 50% Reduction From Baseline in Brief Psychiatric Rating Scale-Positive Symptom Subscale (BPRS-PSS) at Days 7 and 56
Time frame: 56 days
Response as measured by 50% reduction in psychosis at Days 7 and 56 was compared between the group administered placebo and the group administered mifepristone
1 secondary outcome
Proportion of Mifepristone Treated Patients With Plasma Drug Concentrations Equal to or Above 1637 ng/mL vs. Placebo Treated Patients Who Achieve a ≤ 50% Reduction in BPRS-PSS at Days 7 and 56
Time frame: 56 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16889757DeBattista C, Belanoff J, Glass S, Khan A, Horne RL, Blasey C, Carpenter LL, Alva G. Mifepristone versus placebo in the treatment of psychosis in patients with psychotic major depression. Biol Psychiatry. 2006 Dec 15;60(12):1343-9. doi: 10.1016/j.biopsych.2006.05.034. Epub 2006 Aug 4.
- Background: PubMed 16160710Flores BH, Kenna H, Keller J, Solvason HB, Schatzberg AF. Clinical and biological effects of mifepristone treatment for psychotic depression. Neuropsychopharmacology. 2006 Mar;31(3):628-36. doi: 10.1038/sj.npp.1300884.
- 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 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.
- 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.
Thaddeus Block, MD study director
Corcept Therapeutics
42 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 Psychotic Depression and Severe Major Depression With Psychotic Features, run by Corcept Therapeutics at 42 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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 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?
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?
Proportion of Mifepristone vs. Placebo Treated Patients With at Least a 50% Reduction From Baseline in Brief Psychiatric Rating Scale-Positive Symptom Subscale (BPRS-PSS) at Days 7 and 56 (time frame: 56 days). 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 NCT00637494, 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 5 Jun 2017.