A Study to Determine the Efficacy and Safety of 2 Doses of Org 34517 as Adjunctive Therapy in Subjects With Psychotic Major Depression (28130)(P05845) (Hermes)

Inclusion Criteria: have provided voluntary written informed consent for trial participation after the scope and nature of the investigation were explained to them, and before starting any trial-related activities (before Screening); be able to speak, read, understand, respond to questions, and follow instructions in English or their native language; have DSM-IV severe depressive episode with psychotic features, as diagnosed by the MINI for single or recurrent episodes (296.24 or 296.34); 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 the HAMD 17-item scale at Screening and Baseline; be on a stable dose of "usual treatment", which had to consist of an antidepressant, an antipsychotic, a mood stabilizer or any combination of these 3 drug classes; be between 18 and 75 years of age (inclusive) at Screening; be willing to be hospitalized for at least 11 days from Screening onwards. Exclusion Criteria: have any other current psychiatric diagnosis (according to the MINI) except MDD, such as organic mental syndromes and disorders, delirium or anxiety disorders; have a lifetime psychiatric diagnosis of psychotic disorders (according to the MINI), or a MINI diagnosis of past manic episode; be at significant risk of committing suicide, as indicated by a score greater than 9 on the revised InterSePT Scale for Suicidal Thinking (ISST); be currently treated with carbamazepine or valproate; be currently treated with midazolam; be treated with electroconvulsive therapy in the current episode; be currently treated with more than one antidepressant; be currently treated with more than one antipsychotic; be currently treated with more than one mood stabilizer; have a "usual treatment" started or discontinued in the 2 weeks before Randomization; have a "usual treatment" dose change within the week prior to Randomization; have any clinically unstable or uncontrollable renal, hepatic, respiratory, hematological, cardiovascular or cerebrovascular disease that would put the patient at risk of safety or bias assessment of efficacy; have known hypersensitivity reactions to glucocorticoid antagonists; have any clinically significant abnormal laboratory data (e.g. aspartate amino transferase (ASAT) and/or alanine amino transferase (ALAT) values > 2x normal range upper limit) or ECG results, or a clinically significant abnormal outcome at the physical examination at the screening visit; have any untreated or uncompensated clinically significant endocrine disorder; have a MINI diagnosis of alcohol and/or drug dependence; have a confirmed positive result on the drug screening test for any illicit drug, except cannabis, at Screening; be using hormone replacement therapy at Screening; have required concomitant treatment with corticosteroids, like dexamethasone, prednisone or cortisol (topical use is allowed); be diagnosed with Cushing's disease; be women of childbearing potential without adequate contraception; be women with a positive pregnancy test at Screening or Baseline, or breastfeeding mothers; be males with a current diagnosis of prostate hypertrophia or past history (less than 3 months) of symptoms of prostate hypertrophia. be currently treated with clozapine (per Amendment III); be currently treated with systemic or topical ketaconazole.