EUCTR2004-002156-34-CZ进行中（未招募）1 期
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
V Organon0 个研究点目标入组 60 人开始时间: 2006年1月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
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