C-1073-14/A Double Blind Placebo Controlled Study of the Efficacy and Safety of CORLUX (Mifepristone) Vs. Placebo in the Treatment of Psychotic Symptoms in Patients with Major Depressive Disorder with Psychotic Features

Summary

This is a randomized, double blind, placebo-controlled, parallel group, study designed to evaluate the safety and efficacy of CORLUX followed by an antidepressant compared to that of placebo followed by an antidepressant in the treatment of psychotic symptoms in patients with a diagnosis of Major Depressive Disorder with Psychotic Features (DSM-IV 296.24 or 296.34). Approximately 450 patients will be randomized equally (1:1) into 2 treatment groups receiving either CORLUX 1200 mg/day or matching placebo for 7 days. During the 56-day trial, all patients will be administered study drug on Days 1-7, and a single study approved antidepressant during Days 8-56.

Participant Eligibility

1. Participants are 22 to 75 years of age;
2. 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(s), complete study-related procedures, and communicate with the study staff;
3. Have consented to the administration of psychiatric rating scales through 2-way videoconference technology;
4. If not postmenopausal for ≥ 2 years or surgically sterile (6 months post-surgery), must consent 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. Medically acceptable methods of contraception that may be used by the patient and/or the partner include NuvaRing (estradiol vaginal ring), oral contraception (used consistently for 3 months prior to study dosing) or patches, diaphragm with vaginal spermicidal, intrauterine device (IUD), condom and partner using vaginal spermicidal, progestin implant or injection (used consistently for 3 months prior to study dosing);
5. Have a negative serum pregnancy test (serum β-human chorionic gonadotropin) at screening
if female, and a negative urine pregnancy test at baseline;
6. Have a DSM-IV TR diagnosis of Major Depressive Disorder with Psychotic Features (DSMIV
296.24 or 296.34), and are clinically symptomatic with their illness, based on a complete
psychiatric evaluation;
7. Have a DSM-IV TR diagnosis of Major Depressive Disorder with Psychotic Features (DSMIV
296.24 or 296.34), based on the modified Structured Clinical Interview for Diagnosis-
Clinical Trials version (SCID-CT) at screening when performed by a blinded centralized
rater;
8. Have a score of 38 or greater on the BPRS at baseline when performed by a blinded
centralized rater;
9. Have a score of 12 or greater on the BPRS Positive Symptom Subscale (PSS) at baseline
when performed by a blinded centralized rater;
10. Have a score of 20 or greater on the Hamilton Depression (HAMD-24) Scale at baseline when performed by a blinded centralized rater;
11. Have not used antipsychotics, antidepressants and/or mood stabilizers for at least 7 days prior
to randomization. Neither depot antipsychotics nor fluoxetine are allowed for at least 30 days prior to randomization. Anticonvulsants that have been prescribed for a nonpsychiatric indication (neuropathic pain, migraine) may be allowed if the dose has been stable for at least one month prior to randomization