TerminatedNCT00637494Updated Jun 5, 2017Results posted

A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features

A Phase 3 interventional study of mifepristone and placebo in Psychotic Depression, Severe Major Depression With Psychotic Features and Psychosis, sponsored by Corcept Therapeutics. Terminated at 42 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2017-06-05.

Sponsored by Corcept Therapeutics · Phase 3, Interventional, and Treatment

Why this study was terminated

DRC recommended stopping study as it had missed its primary endpoint

Phase: Phase 3
Study type: Interventional
Enrollment: 292
Allocation: Randomized
Ages: 22 Years and older
Sex: All

Study 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 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.

Conditions studied

Psychotic Depression
Severe Major Depression With Psychotic Features
Psychosis

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Keywords

psychotic depression
major depression with psychotic features
psychosis

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 292 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Corcept Therapeutics is the lead sponsor of 73 studies on the registry; 4 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 9 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 22 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 292 participants (actual)

Study arms

Active comparator
1
Mifepristone followed by an antidepressant
Drug: mifepristone
Placebo comparator
2
Placebo followed by an antidepressant
Drug: placebo

Interventions

Drugmifepristone
1200 mg (administered as four 300 mg tablets) once a day by mouth for the initial 7 days
Also known as: Korlym
Drugplacebo
Tablets of identical appearance to active drug, once a day by mouth for the initial 7 days
Also known as: control

What researchers measure

Primary outcomes

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
Time frame: 56 days

Secondary outcomes

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
Time frame: 56 days

Results

Posted Feb 16, 2017

Participant flow

Participant flow — Overall Study
Milestone	Mifepristone 1200 mg/Day	Matching Placebo
Started	141	151
Completed	109	108
Not completed	32	43

Outcome measures

PrimaryProportion 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

Time frame:: 56 days
Reported as:: Number · participants

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
participants	Active	Placebo
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	51	48

SecondaryProportion 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

Time frame:: 56 days
Reported as:: Number · participants

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
participants	Active	Placebo
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	37	48

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Mifepristone 1200 mg/Day	—	3/141 (2.1%)	115/141 (81.6%)
Matching Placebo	—	4/151 (2.6%)	103/151 (68.2%)

Most frequent serious events

Most frequent serious events
Event	Mifepristone 1200 mg/Day	Matching Placebo
DepressionNervous system disorders	1/141	2/151
Suicidal IdeationNervous system disorders	0/141	2/151
Chronic Obstructive Pulmonary DiseaseRespiratory, thoracic and mediastinal disorders	1/141	0/151
Psychotic DisorderNervous system disorders	1/141	0/151

Most frequent other events

Showing 10 of 15

Most frequent other events
Event	Mifepristone 1200 mg/Day	Matching Placebo
HeadacheNervous system disorders	33/141	29/151
NauseaGastrointestinal disorders	25/141	19/151
ConstipationGastrointestinal disorders	17/141	14/151
Dry MouthGastrointestinal disorders	15/141	9/151
InsomniaPsychiatric disorders	8/141	16/151
DyspepsiaGastrointestinal disorders	14/141	9/151
DiarrhoeaGastrointestinal disorders	11/141	14/151
PollakiuriaRenal and urinary disorders	12/141	5/151
VomitingGastrointestinal disorders	11/141	8/151
DizzinessNervous system disorders	11/141	9/151

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Mifepristone Followed by an Antidepressant	Matching Placebo	Total
<=18 years	0	0	0
Between 18 and 65 years	141	147	288
>=65 years	0	4	4

Age, Continuous
Age, Continuous(years)	Mifepristone Followed by an Antidepressant	Matching Placebo	Total
Mean	45.4 ± 9.0	47.0 ± 9.5	46.2 ± 9.3

Sex: Female, Male
Sex: Female, Male(Participants)	Mifepristone Followed by an Antidepressant	Matching Placebo	Total
Female	76	85	161
Male	65	66	131

Region of Enrollment
Region of Enrollment(participants)	Mifepristone Followed by an Antidepressant	Matching Placebo	Total
United States	141	151	292

Study locations

42 sites

K&S Professional Research Services, LLC
Little Rock, Arkansas 72201, United States
Woodland International Research Group, Inc.
Little Rock, Arkansas 72211, United States
South Coast Clinical Trials, Inc
Anaheim, California 92804, United States
Diligent Clinical Trials
Downey, California 90241, United States
Synergy Clinical Research Center
Escondido, California 92025, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California 92845, United States
Pacific Research Partners
Oakland, California 94612, United States
North County Clinical Research
Oceanside, California 92056, United States
Breakthrough Clinical Trials
San Bernardino, California 92408, United States
Sharp Mesa Vista Hospital
San Diego, California 92123, United States
Cnri, Llc
San Diego, California 92126, United States
Professional Clinical Research, Inc.
Aventura, Florida 33180, United States
University of Florida
Gainesville, Florida 32606, United States
Segal Institute for Clinical Research
Hollywood, Florida 33021, United States
Accurate Clinical Trials
Kissimmee, Florida 34741, United States
AMB Research Center
Miami, Florida 33144, United States
Lakeside Behavioral Health
Orlando, Florida 32810, United States
University of South Florida Dept of Psychiatry and Neurosciences
Tampa, Florida 33613, United States
Atlanta Center for Medical Research
Atlanta, Georgia 30308, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois 60169, United States
Precise Research Centers
Flowood, Mississippi 39232, United States
Millennium Psychiatric Associate
Creve Coeur, Missouri 63141, United States
PsychCare Consultants Research
Saint Louis, Missouri 63128, United States
CRI Lifetree
Marlton, New Jersey 08053, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York 11516, United States
The Zucker Hillside Hospital
Glen Oaks, New York 11004, United States
Inquest Clinical Group/ Global Research Associates
Hope Mills, North Carolina 28348, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina 27157, United States
Midwest Clinical Research Center
Dayton, Ohio 45417, United States
Oklahoma Clinical Research Center
Oklahoma City, Oklahoma 73112, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania 18104, United States
Belmont Center for Comprehensive Treatment
Philadelphia, Pennsylvania 19131, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania 15213, United States
Carolina Clinical Trials, Inc.
Charleston, South Carolina 29405, United States
FutureSearch Clinical Trials, L.P.
Austin, Texas 78731, United States
Pillar Clinical Research, LLC
Dallas, Texas 75243, United States
University of Texas Southwestern Medical Center
Dallas, Texas 75390, United States
InSite Clinical Research, LLC
DeSoto, Texas 75115, United States
Claghorn-Lesem Research Clinic
Houston, Texas 77008, United States
Clinical Trial Network
Houston, Texas 77074, United States
Fein-Jennings Clinic, Inc.
Houston, Texas 77074, United States
Lifetree Clinical Research
Salt Lake City, Utah 84106, United States

References and documents

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 16889757 ↗
Flores 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 16160710 ↗
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 ↗
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 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00637494
Lead sponsor: Corcept Therapeutics
Responsible party: Sponsor
First posted: Mar 18, 2008
Start date: Mar 2008
Primary completion: Jun 2014
Completion: Jun 2014
Results posted: Feb 16, 2017
Last update: Jun 5, 2017

Study contacts

Thaddeus Block, MD

study director · Corcept Therapeutics

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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