An International Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression

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Corcept Therapeutics

Status and phase

Completed
Phase 3

Conditions

Major Depressive Disorder

Treatments

Drug: placebo
Drug: Mifepristone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00146523
C-1073-09

Details and patient eligibility

About

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).

Enrollment

247 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Are 18 to 75 years of age
  • Have a diagnosis of major depressive disorder with psychotic features (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM IV] 296.24 or 296.34)
  • Are able to provide written informed consent.

Exclusion criteria

  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

247 participants in 2 patient groups, including a placebo group

mifepristone 600 mg
Experimental group
Treatment:
Drug: Mifepristone
matching placebo
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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