Clinical trial NCT00212797 (phase 2, status: completed)
Conditions: depression, depressive disorders, psychotic disorders
ICD codes: F32.A, F53.0, P91.4, Z13.31, Z13.32, F23, F24, F12.159, F12.259, F12.150, F12.151, F12.250
Drugs: org 34517, org 34517, placebo
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, 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, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        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.