Clinical trial NCT00208156: A United States Extension Study of Corlux for Recurrent Psychotic Symptoms in Psychotic Major Depression
Official title: An Open-Label Extension Study of the Safety and Tolerability of CORLUX™ (Mifepristone) for Recurrent Psychotic Symptoms in Patients With Major Depressive Disorder With Psychotic Features
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder, Major
Keywords: Depression
Major Depression
Psychotic Major Depression
PMD
Psychosis
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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 study is to allow patients who have already participated in an earlier 8 week study of Corlux versus placebo (an inactive pill) to receive additional courses of treatment with Corlux periodically if a psychotic episode should reappear during a period of one year.


Eligibility criteria: Inclusion Criteria:

* Completed participation through Day 56 in Corcept Therapeutics Protocol C-1073-07
* Are 18 to 75 years of age
* Have a diagnosis of major depressive disorder with psychotic features (DSM-IV 296.24 or 296.34)
* Are able to provide written informed consent

Exclusion Criteria:

* Have a major medical problem
* Have a history of an allergic reaction to Corlux (C-1073, mifepristone)

Primary outcomes:
measure: To evaluate the safety and tolerability of Corlux (mifepristone) for the treatment of recurrent psychotic symptoms with major depression with psychotic features (PMD) who previously participated in Corcept Therapeutics Protocol C-1073-07
Secondary outcomes:
measure: To assess the frequency of retreatment with Corlux in patients with PMD and qualitatively describe the psychotic symptoms for which retreatment is clinically indicated
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Cnri, Llc
state: California
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Las Vegas
country: United States
facility: Robert Horne M.D.
state: Nevada
city: Clementon
country: United States
facility: CNS Research Institute (CRI)
state: New Jersey
city: Newark
country: United States
facility: New Jersey Medical School - UMDNJ
state: New Jersey
city: Toms River
country: United States
facility: BioBehavioral Health
state: New Jersey
city: Glen Oaks
country: United States
facility: Zucker Hillside Hospital
state: New York
city: Lawrence
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Philadelphia
country: United States
facility: CNS Research Institute (CRI)
state: Pennsylvania
city: Bellaire
country: United States
facility: Claghorn-Lesem Research Clinic
state: Texas
city: Richmond
country: United States
facility: International Clinical Research Associates
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Corcept Therapeutics
name: Katherine Beebe, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Brogden RN, Goa KL, Faulds D. Mifepristone. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential. Drugs. 1993 Mar;45(3):384-409. doi: 10.2165/00003495-199345030-00007.
citation: 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.