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Last Updated: May 27, 2022

CLINICAL TRIALS PROFILE FOR KORLYM


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All Clinical Trials for Korlym

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00637494 ↗ A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features Terminated Corcept Therapeutics Phase 3 2008-03-01 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.
NCT01631682 ↗ Pilot Study of Pharmaceutical and Behavioral Interventions to Treat Anxiety Disorders Completed Massachusetts General Hospital Phase 4 2010-11-01 The aim of this project is to create fear conditioning paradigm within which the relative strengths of various novel pharmacological and behavioral interventions can be tested. These interventions are intended to reduce the fearfulness associated with fear conditioning by blocking a memory process known as reconsolidation. In fear conditioning, a "conditioned" stimulus (CS) is paired with an aversive "unconditioned" stimulus (US) such as an electric shock, until presentation of the CS alone comes to elicit a fear conditioned response (CR). The investigators hypothesize that by using a more highly prepared CS (i.e. video of spiders); more sensitive subjects (individuals with stronger acquired CRs); and additional experimental probes for the presence of the latent CR, the investigators may develop a normal human paradigm that is not plagued by previously observed floor effects (i.e. intervention is 100% effective), within which both the established techniques of propranolol and delayed extinction will produce significant, but only partial, CR reduction. This would leave room to test and compare potentially more powerful candidate reconsolidation-blocking or memory-updating interventions. To achieve these aims, subjects will undergo a four-day fear conditioning and delayed extinction protocol. Skin conductance response data will be gathered across the different phases of the experiment.
NCT01739335 ↗ Novel Therapeutics in Posttraumatic Stress Disorder (PTSD): A Randomized Clinical Trial of Mifepristone Completed VA Office of Research and Development Phase 2 2012-11-19 Posttraumatic stress disorder (PTSD) is a common and disabling psychiatric disorder for Veterans. Left untreated or under-treated, it can become a chronic condition associated with significant distress, depression, aggression, family disruption, substance abuse and an increased risk of morbidity and mortality. Considerable advances were made in the treatment of PTSD in recent years; however, psychopharmacological treatments have been shown to be largely ineffective for Veterans with PTSD. To address this gap, this proposal seeks to test an innovative treatment approach in PTSD - pharmacological manipulation of the body's major stress system (the hypothalamic-pituitary-adrenal (HPA) axis) with mifepristone. At high doses mifepristone is a glucocorticoid receptor (GR) antagonist with peripheral and central nervous system effects, making it a compound of interest in the treatment of stress related disorders. There is abundant evidence of enhanced GR sensitivity in Veterans with PTSD which is thought to underlie some of the symptoms of PTSD and associated disturbances in mood and cognition. There is also evidence that short-term mifepristone treatment has sustained beneficial effects on mood, cognition and sleep disturbance in some neuropsychiatric conditions (major depression, bipolar disorder, primary insomnia). The purpose of the study is to examine the effects of mifepristone to determine if it is efficacious in improving PTSD symptoms and associated clinical outcomes. To achieve these objectives, the investigators propose to conduct a Phase IIa, multi-site, double-blind, placebo controlled trial of mifepristone in male Veteran outpatients with chronic PTSD through the VA's Cooperative Clinical Trial Award program. The investigators propose to enroll 90 subjects at multiple VA sites based on an estimated attrition rate of 20%. Eligible Veterans will be randomly assigned to the treatment of mifepristone (600 mg/day) or placebo for one week and followed for up to three months. The investigators will also describe the effects of mifepristone on several other clinical parameters including PTSD symptomology, depression severity, sleep quality, and functional impairment. Several measures of neuroendocrine functioning will also be obtained to explore the relationship of plasma cortisol and adrenocorticotropic hormone (ACTH) levels to clinical response and the time to addition of rescue medications.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Korlym

Condition Name

Condition Name for Korlym
Intervention Trials
Stress Disorders, Post-Traumatic 2
Mild Hypercortisolism 1
Posttraumatic Stress Disorder 1
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Condition MeSH

Condition MeSH for Korlym
Intervention Trials
Stress Disorders, Traumatic 3
Stress Disorders, Post-Traumatic 3
Alcoholism 2
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Clinical Trial Locations for Korlym

Trials by Country

Trials by Country for Korlym
Location Trials
United States 31
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Trials by US State

Trials by US State for Korlym
Location Trials
California 6
New York 4
North Carolina 3
New Mexico 2
Maryland 2
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Clinical Trial Progress for Korlym

Clinical Trial Phase

Clinical Trial Phase for Korlym
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Korlym
Clinical Trial Phase Trials
Completed 6
Terminated 2
Recruiting 1
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Clinical Trial Sponsors for Korlym

Sponsor Name

Sponsor Name for Korlym
Sponsor Trials
National Institute on Alcohol Abuse and Alcoholism (NIAAA) 2
Corcept Therapeutics 2
VA Office of Research and Development 2
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Sponsor Type

Sponsor Type for Korlym
Sponsor Trials
Other 6
U.S. Fed 5
NIH 3
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