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

Phase 1

• Conditions: Psychotic major depression (major depressive episode, severe, with psychotic features); MedDRA version: 6.1Level: LLTClassification code 10037250

• Registration Number: EUCTR2004-002156-34-CZ
• Lead Sponsor: V Organon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-09
• Study Completion: 2006-06-16
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

a) 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;
b) have attended Screening, Baseline, Visit Day 15, Day 29 and Day 43 of trial 28130;
c) have a CGI of Severity score of 3 or greater at Day 43 of trial 28130 and at Day 1 of trial 28133, or a lower score when the investigator is of the opinion that further resolution of symptoms is warranted; and
d) 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a) have experienced any of the following significant safety outcomes in trial 28130:
1. Severe breakthrough bleeding;
2. Diagnosis of prostatitis;
3. Abnormal level of testosterone at Day 15 of trial 28130;
4. A significant increase in suicidality at any time point as evidenced by an ISST score > 9 or an increase of 3 points or more post-randomisation;
5. A doubling of trial 28130 screening values in two or more tests of hepatic function (ASAT, ALAT, bilirubin, alkaline phosphatase or gamma GT);
6. Emergent dermatological condition or worsening of a pre-existing dermatological condition;
7. A clinically significant abnormal ECG, as judged by the QECG cardiologist;
8. For male subjects: Obstructive urinary symptoms;
9. Any adverse event deemed relevant for exclusion in trial 28133 by the investigator.
b) have an abnormal PSA test at Day -7 of trial 28133
c) are at significant risk of committing suicide, as indicated by a score greater than 9 on the revised ISST at Day -7 or Day 1;
d) are currently treated with carbamazepine or valproate;
e) are currently treated with midazolam;
f) are currently treated with clozapine;
g) have been treated with electroconvulsive therapy (ECT) in the current episode;
h) are currently treated with more than one antidepressant;
i) are currently treated with more than one antipsychotic;
j) are currently treated with more than one mood stabilizer;
k) have ‘usual treatment’ started or discontinued in the 2 weeks before Day 1;
l) have a ‘usual treatment’ dose change within one week prior to Day 1;
m) 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;
n) have known hypersensitivity reactions to glucocorticoid antagonists;
o) 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 Day -7;
p) have a confirmed positive result on the drug screening test for any illicit drug, except cannabis, at Day -7;
q) have any untreated or uncompensated clinically significant endocrine disorder;
r) are using hormone replacement therapy at Day -7;
s) require concomitant treatment with corticosteroids, like dexamethasone, prednisone or cortisol (topical use is allowed);
t) are women of childbearing potential without adequate contraception (an IUD, oral contraceptives in combination with a barrier method or a condom combined with spermicide, are considered adequate); or
u) are women with a positive pregnancy test at Day -7 or 1, or are breast feeding mothers;
v) are currently treated with systemic or topical ketaconazole.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified