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

Study Overview
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Brief Summary
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Patients who participated in the previous trial 28130, who were eligible, were entered into this trial. Patients who were randomized to placebo in the previous trial 28130 continued on placebo while patients who were randomized to Org 34517 (SCH 900636), regardless of dose, were titrated to 900 mg Org 34517. Patients in this trial took their study medication for 2 weeks in order to study the safety and tolerability of Org 34517.

Official Title
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Double-blind, Placebo-controlled Trial Investigating the Safety of Re-exposure to 900 mg of Org 34517, Used as Adjunctive Therapy in Subjects With Psychotic Major Depression (Major Depressive Episode, Severe, With Psychotic Features), Who Participated in Trial 28130

Conditions
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Depressive Disorders, Psychotic Disorders, Depression

Intervention / Treatment
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* Drug: SCH 900636
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Org 34517<br>Org 34517 titrated to 900 mg daily for 2 weeks | Drug: SCH 900636<br>* Org 34517 300 mg on Day 1, 600 mg on Day 2, then 900 mg daily starting from Day 3. Subjects in this arm were also to continue the usual treatment for psychotic major depression.<br>* Other names: Org 34517;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability measures (vital signs, AEs) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 17-item Hamilton Rating Scale for Depression (HAMD) total score |  | 4 weeks | 
| proportion of BPRS 30% responders; proportion of subjects with sustained BPRS 30% response |  | 4 weeks | 
| proportion of HAMD 50% responders; proportion of subjects with sustained HAMD 50% response |  | 4 weeks | 
| clinical global impression (CGI) |  | 4 weeks | 
| PANNS total score |  | 4 weeks | 
| PANSS positive scale score, PANSS negative scale score, PANSS general psychopathology score |  | 4 weeks |