Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 1:35 AM
NCT ID:
NCT00637494
Eligibility Criteria:
Inclusion Criteria:
* 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, complete study-related procedures, and communicate with the study staff
* Have a DSM-IV TR diagnosis of Major Depressive Disorder with Psychotic Features (DSM-IV 296.24 or 296.34), and are clinically symptomatic with their illness
* Have pre-specified minimum scores on standardized psychiatric rating scales at baseline
* Have not been taking excluded medication for at least 7 days prior to randomization
* Have a negative pregnancy test
* If not postmenopausal for ≥ 2 years or surgically sterile (6 months post-surgery), must consent (patient or partner) 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
Exclusion Criteria:
* Have any primary psychiatric diagnosis other than psychotic depression.
* Have a major medical problem, which in the opinion of the investigator would place the patient at undue risk.
* Have undergone electroconvulsive therapy within 3 months prior to randomization
* Have had a hospitalization due to a suicide attempt within 45 days prior to randomization
* Are female and of childbearing age, and are unable or unwilling to use two medically acceptable methods of contraception during the study and for three months after study completion, one of which must be a barrier method
* Are female and are pregnant or lactating
* Are currently taking excluded medications
* Have used drugs of abuse within 30 days prior to screen, as per patient report and urine drug screen
* Have a history of active drug or alcohol abuse within 3 months or dependence within 6 months prior to screening
* Are in the opinion of the investigator at immediate risk of suicide, or at risk of harming others
* Have received investigational therapy (drug, vaccine, biological agent or device) within 6 months prior to randomization
* Have previously participated in a clinical trial of mifepristone
* Have a history of an allergic reaction to mifepristone
* Are in the investigator's opinion not appropriate for participation in the study or may not be capable of following the study schedule for any reason
* Are patients who are employees of the study unit or their family members, students who are working in the study unit, or family members of the investigator or Corcept Therapeutics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT00637494
Study Brief:
Protocol Section:
NCT00637494