Prospective, double-blind, randomized, placebo-controlled dose finding study of the efficacy and safety of 2 target doses of Org 34517 used as adjunctive therapy in subjects with psychotic major depression (major depressive episode, severe, with psychotic features)

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

• Registration Number: EUCTR2004-000050-23-GB
• Lead Sponsor: V Organon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-15
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

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 (before Screening);
b) be able to speak, read, understand, respond to questions, and follow instructions in English or their native language, if the investigator is fluent in that language and any required documents, including informed consent, can be translated into that language;
c) have a DSM-IV severe depressive episode with psychotic features, as diagnosed by the MINI-Plus for single or recurrent episodes (296.24 or 296.34);
d) have a score on PANSS item Delusions” AND/OR Hallucinatory behavior” of at least 4 at Screening and Baseline;
e) have a PANSS Positive Scale score of at least 16 at Screening and Baseline;
f) have a total score of at least 18 on the HAMD 17 item scale at Screening and Baseline;
g) be on a stable dose of usual treatment”, which has to consist of an antidepressant, an antipsychotic, a mood stabilizer or any combination of these 3 drug classes;
h) be 18 up to and including 70 years of age at Screening;
i) must be willing to be hospitalized for at least 11 days from Screening onwards. Interval between Screening and Baseline is 2 - 3 days and 1 day is needed for confirmation of the diagnosis and subsequent randomization. Subjects will be treated as inpatients for at least 1 week after Randomization. After this period subjects may be treated on an outpatient basis if the investigator is of the opinion that it is safe to do so.

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 any other current psychiatric diagnosis (according to the MINI-Plus) except MDD, such as organic mental syndromes and disorders, delirium or anxiety disorders;
b) have a lifetime psychiatric diagnosis of psychotic disorders (according to the MINI), or a MINI diagnosis of past manic episode. Subjects with a MINI diagnosis of past hypomanic episode can be enrolled, provided that their current episode is not hypomanic. Subjects with a MINI diagnosis of panic disorder lifetime can be enrolled, provided that they do not have the MINI diagnosis of panic disorder current;
c) are at significant risk of committing suicide, as indicated by a score greater than 9 on the revised ISST;
d) are currently treated with carbamazepine or valproate;
e) are currently treated with midazolam;
f) have been treated with electroconvulsive therapy (ECT) in the current episode;
g) are currently treated with more than one antidepressant;
h) are currently treated with more than one antipsychotic;
i) are currently treated with more than one mood stabilizer;
j) have usual treatment” started or discontinued in the 2 weeks before Randomization.
k) have a usual treatment” dose change within the week prior to Randomization;
l) 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;
m) have known hypersensitivity reactions to glucocorticoid antagonists;
n) 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;
o) have any untreated or uncompensated clinically significant endocrine disorder;
p) have a MINI-Plus diagnosis of alcohol and/or drug dependence;
q) have a confirmed positive result on the drug screening test for any illicit drug, except cannabis, at Screening;
r) are using hormone replacement therapy at Screening;
s) require concomitant treatment with corticosteroids, like dexamethasone, prednisone or cortisol (topical use is allowed);
t) are subjects diagnosed with Cushing’s disease;
u) are women of childbearing potential without adequate contraception (an IUD or oral contraceptives in combination with a barrier method are considered adequate);
v) are women with a positive pregnancy test at Screening or Baseline, or are breastfeeding mothers;
w) Are male subjects with a current diagnosis of prostate hypertrophia or past history (less than 3 months) of symptoms of prostate hypertrophia. Subjects, whose symptoms of prostate hypertrophia were not more recent than 3 months, may be included based on a negative Prostate-Specific Antigen (PSA) test (PSA blood level lower than 4.0 ng/mL) and medical judgment.

Study & Design

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