Safety of Org 34517 900 mg in Patients Who Received Org 34517 in a Previous Trial (Study 28133/P05842)

Inclusion criteria

• have attended Screening, Baseline, Visit Day 15, Day 29 and Day 43 of previous trial 28130;
• have a CGI of Severity score of 3 or greater at Day 43 of previous trial 28130 and at Day 1 of current trial 28133, or a lower score when the investigator is of the opinion that further resolution of symptoms is warranted;
• be on a stable dose of 'usual treatment', which must consist of an antidepressant, an antipsychotic, a mood stabilizer or any combination of these 3 drug classes.

Exclusion criteria

• had experienced any of the following significant safety outcomes in previous trial 28130:

• severe breakthrough bleeding;
• diagnosis of prostatitis;
• abnormal level of testosterone at Day 15 of previous trial 28130;
• any adverse event deemed relevant for exclusion in trial 28133 by the investigator.
• had an abnormal PSA test at Day -7 of previous trial 28133
• were at significant risk of committing suicide, as indicated by a score greater than 9 on the revised ISST at Day -7 or Day 1;
• were currently treated with carbamazepine or valproate, midazolam, or clozapine;
• had been treated with electroconvulsive therapy (ECT) in the current episode;
• were currently treated with more than one antidepressant, antipsychotic, or mood stabilizer;
• had 'usual treatment' started or discontinued in the 2 weeks before Day 1;
• had a 'usual treatment' dose change within one week prior to Day 1;
• had 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;
• had known hypersensitivity reactions to glucocorticoid antagonists;
• had 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 Day -7;
• had a confirmed positive result on the drug screening test for any illicit drug, except cannabis, at Day -7;
• had any untreated or uncompensated clinically significant endocrine disorder;
• were using hormone replacement therapy at Day -7;
• required concomitant treatment with corticosteroids (topical use was allowed);
• women of childbearing potential without adequate contraception
• women with a positive pregnancy test at Day -7 or 1, or are breast feeding mothers.