Safety Study of ORG 34517 for Major Depression With Psychotic Features

Inclusion Criteria: * provide voluntary written informed consent for trial participation after the scope and nature of the investigation have been explained to them, and before starting any trial related activities * be able to speak, read, understand, respond to questions and follow instructions in English * have a DSM-IV severe depressive episode with psychotic features, as diagnosed by the MINI for single or recurrent episodes * have a score on PANSS item "Delusions" AND/OR "Hallucinatory behavior" of at least 4 at screening and baseline * have a PANSS Positive Scale score of at least 16 at screening and baseline * have a total score of at least 18 on teh HAMD 17 item scale at Screening and Baseline * be on a stable dose of usual treatment which has to consist of an anti-depressant, an antipsychotic, a mood stabilizer or any combination of these three drug classes * be 18 up to and including 70 years of age at Screening * must be willing to be hospitalized for at least 11 days from Screening onwards. Exclusion Criteria: * have any other psychiatric diagnosis except MDD * have a lifetime psychiatric diagnosis of Bipolar Disorder I, schizophrenia or schizoaffective disorders * are at significant risk of committing suicide * are currently treated with carbamazepine or valproate * are currently treated with midazolam * have been treated with electroconvulsive therapy in the current episode * are currently treated with more than one antidepressant * are currently treated with more than one antipsychotic * are currently treated with more than one mood stabilizer * have usual treatment started or discontinued in the two weeks before randomization * have a usual treatment dose change within the week prior to randomization * have any clinically unstable or uncontrollable renal, hepatic, respiratory, haematological, cardiovascular or cerebrovascular disease that would put the patient at risk of safety or bias assessment efficacy * have known hypersensitivity reactions to glucocorticoid antagonists * have any clinically significant abnormal laboratory data * have any untreated or uncompensated clinically significant endocrine disorder * have a diagnosis or alcohol and/or drug dependence * have a confirmed positive result on the drug screening test for any illicit drug except cannabis * are using hormone replacement therapy at Screening * require concomitant treatment with corticosteroids * are subjects diagnosed with Cushing disease * are women of childbearing potential without adequate contraception * are women with a positive pregnancy test at screening or baseline or are breastfeeding mothers * are male subjects with current diagnosis of prostrate hypertrophia or past history of symptoms of prostrate hypertrophia.