Clinical trial NCT00226278 (phase 2, status: completed)
Conditions: major depressive disorder, psychotic disorders
ICD codes: F33.0, F33.1, F33.9, F32.0, F32.1, F32.9, F33.40, F23, F24, F12.159, F12.259, F12.150, F12.151, F12.250
Drugs: org 34517
SMILES: CC#C[C@]1(O)CC[C@H]2[C@@H]3CCC4=CC(=O)CCC4=C3[C@H](C[C@]12C)C1=CC=C2OCOC2=C1
Eligibility criteria:

        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.