EUCTR2004-002560-17-DE进行中（未招募）不适用
A Multicenter, Double-Blind, Flexible-Dose, 6-Month Trial Comparing the Efficacy and Safety of Asenapine With Olanzapine in Stable Subjects With Predominant, Persistent Negative Symptoms of Schizophrenia - Aphrodite
V Organon0 个研究点目标入组 444 人开始时间: 2005年4月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 444
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
- •Subjects are eligible to participate in the study if they:
- •Demographic
- •1. are at least 18 years of age;
- •2. are a male, or a female who is not of childbearing potential (ie, surgically sterile, postmenopausal for at least 1 year) or who is non-pregnant, non-lactating, and using a method of birth control that is acceptable to the investigator;
- •3. sign written informed consent after the scope and nature of the investigation have
- •been explained to them before screening evaluations. Subjects unable or incapable
- •of signing may participate if the legal representative provides consent and the subject affirms their participation;
- •4. are fluent in the language of the investigator, study staff (including raters), and the informed consent;
- •5. have a caregiver or an identified responsible person (eg, family member, social
- •worker, caseworker, or nurse) considered reliable by the investigator in providing
- •support to the subject to ensure compliance with study treatment, outpatient visits
- •and protocol procedures;
- •6. have a documented current diagnosis of schizophrenia of paranoid (295.30),
- •disorganized (295.10), catatonic (295.20), residual (295.60), or undifferentiated
- •(295.90) subtype (the Mini International Neuropsychiatric Interview [MINI] interview
- •will be used);
- •7. have a minimum PANSS negative subscale score of 20 at screening and baseline,
- •with a minimum score of 4 (moderate) on at least 3 of the Marder factors for negative
- •symptoms (blunted affect [N1], emotional withdrawal [N2], poor rapport [N3], passive social withdrawal [N4], lack of spontaneity [N6], motor retardation [G7], active social avoidance [G16]);
- •8. have a PANSS positive subscale (Marder factor) score < the PANSS negative subscale (Marder factor) score at screening and baseline; and
- •9. have demonstrated clinical stability for the past 5 months at time of screening,
- •defined as:
- •no significant changes in schizophrenia symptomatology (changes in medication or medication dosing may be acceptable);
- •no hospitalizations for the symptoms of schizophrenia during the past 5 months;
- •no increase in level of psychiatric care during the past 5 months due to worsening of symptoms of schizophrenia;
- •no jailing or imprisonment in the past 5 months due to worsening of symptoms of
- •schizophrenia.
- •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
- •Potential subjects will be excluded at screening if they:
- •Medical Status
- •1. have an uncontrolled, unstable clinically significant medical condition (eg, renal,
- •hepatic, endocrine, respiratory, cardiovascular, hematologic, immunologic,
- •cerebrovascular disease, anorexia [body mass index (BMI) <18.5 kg/m2] or obesity
- •[BMI >35 kg/m2], or malignancy) that may interfere with the interpretation of safety or efficacy evaluations in the opinion of the investigator;
- •2. have any clinically significant abnormal laboratory, vital sign, physical examination,
- •or ECG findings at screening and any significant changes by baseline that, in the
- •opinion of the investigator, may interfere with the interpretation of safety or efficacy
- •evaluations;
- •3. have a positive result on the serum pregnancy test or are breast feeding at
- •screening, or intend to become pregnant during the course of the trial;
- •4. have narrow angle glaucoma;
- •5. have a seizure disorder beyond childhood or are taking any anticonvulsants to
- •prevent seizures;
- •6. have known serological evidence of human immunodeficiency virus (HIV) antibody;
- •7. have a history of neuromalignant syndrome (NMS);
- •Psychiatric
- •8. have a score of 3 or greater on the global Parkinson item of the ESRS-A;
- •9. have depressive symptoms as defined by a score of 9 or greater on the CDSS;
- •10. have a rating of 4 or higher on 2 or more items in the PANSS positive symptom
- •subscale including items for delusions, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution;
- •11. have a substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse;
- •12. have current (past 5 months) substance abuse/dependence according to DSM-IV-TRTM criteria (excluding nicotine);
- •13. have a concurrent psychiatric disorder other than schizophrenia coded on Axis I, a primary diagnosis other than schizophrenia including depression;
- •14. have a diagnosis of mental retardation or severe organic brain syndromes;
- •15. present an imminent risk of self-harm or harm to others;
- •16. Have a score of 2 on items 7, 10, or 11 on the ISST-modified at screening;
- •17. have been treated with olanzapine in the previous 5 months (at adequate doses for at least 3 months) and had an inadequate response with respect to treatment of negative symptoms;
- •18. have a history of hypersensitivity to olanzapine;
- •19. have been treated with clozapine in the previous 5 months for treatment-resistant schizophrenia (i.e. at least two other antipsychotic treatments have been unsuccessful before clozapine was prescribed);
- •20. have received antidepressants and/or mood stabilizers to treat a depressive disorder (Axis I) or had antidepressant medication or antidepressant dose changes due to clinically unstable depressive symptomatology, during the 5 month period prior to the Screening visit;
- •21. have previously been treated in an asenapine trial;
- •22. have taken an investigational drug within 30 days prior to baseline;
- •23. require high doses of benzodiazepines (=4 mg per day lorazepam or equivalent); or
- •24. have been judged by the investigator to be medically non-compliant in the
- •management of their disease.
- •Subjects are eligible for randomization if they have:
- •25. the same CGI-S of Illness scores from screening to baseline; and
- •26. baseline PANSS total score and PANSS negative subscale (Marder factor) score of ±20% from Screening.
研究者
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