Mifepristone in the Treatment of Psychotic Depression

Corcept is conducting a Phase 3 study of the effects of mifepristone on the psychotic features of psychotic depression. The FDA has granted Corcept “Fast Track” status for this product candidate. Fast track status is a process designed to speed the development and approval of drugs to treat serious diseases that fill an unmet medical need.

Current Treatment Options

There is no FDA-approved treatment for psychotic depression. Patients with psychotic depression are often hospitalized because patients require protection due to the presence of suicidal thoughts or because they are receiving Electro-convulsive Therapy (ECT), a procedure which requires careful supervision because of its side effects. There are approximately 100,000 psychotic depression - related hospitalizations per year in the United States. often because patients require protection due to the presence of suicidal thoughts or because they are receiving Electro-convulsive Therapy (ECT), a procedure which requires careful supervision because of its side effects. Patients with psychotic depression are frequently incapacitated, and are unable to maintain interpersonal relationships, or keep a job.

Electroconvulsive Therapy (ECT): During ECT a patient receives an electrical current to the brain until a seizure is induced. General anesthesia and muscle relaxants are used to minimize discomfort and to avoid fractures of the spine that otherwise could result from the ECT-induced seizures. After awakening, the patient is confused and almost always experiences a degree of memory loss. Although this memory loss is often centered around the event of the ECT procedure. It sometimes is more profound and may involve significant intervals of time or major events in the patient's life.

In general, a patient will receive two or three ECT treatments per week over a 3-5 week period. ECT is available in some centers on an outpatient basis, although many patients require hospitalization.

Antipsychotics and Antidepressants: Patients often decline ECT due to the stigma or side effects associated with the procedure. The combination of an antidepressant such as Prozac®, Zoloft®, or Celexa® and an antipsychotic like Haldol®, or Zyprexa® works more slowly (if at all) and can produce its own undesirable side effects, including weight gain, Type II diabetes, sedation and movement disorders.

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