EUCTR2006-005585-40-CZ进行中（未招募）不适用
A randomized, parallel group, multiple dose, 6 week study to evaluate safety, tolerability, and pharmacokinetics of asenapine in elderly subjects with psychosis. - N/A
V Organon0 个研究点目标入组 120 人开始时间: 2007年1月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- •General Inclusion Criteria:
- •Subjects should:
- •1. be male or female subjects, 65 years of age or greater.
- •2. willing to sign written informed consent (subjects unable or incapable of signing may participate if the legally authorized representative provides consent and the subject affirms their participation).
- •3. be fluent in the language of the investigator, and study staff (including raters) and informed consent
- •4. 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.
- •Subjects should:
- •1. have psychotic symptoms as evidenced by a score of 4 or more on at least 1 of the following PANSS items:
- •P1 Delusions
- •P3 Hallucinatory behavior
- •P4 Excitement
- •P7 Hostility
- •G14 Poor Impulse Control
- •2. have a minimum PANSS total score >50 at screening.
- •3. have a Clinical Global Impression – Severity of Illness (CGI S) scale score of at least 3 at screening.
- •Pre-trial medication
- •Subjects should:
- •1. have responded positively to an antipsychotic medication other than clozapine (Clozaril®).
- •2. have discontinued depot neuroleptics prior to first dose (Day 1) (last dose of depot neuroleptics should be received more than 1 dosing interval minus 1 week prior to first dose).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •Subjects should be excluded from the trial if they:
- •Psychiatric Exclusion Criteria
- •1. have current (within 6 months prior to screening) DSM IV TR™ defined substance abuse/dependence (excluding nicotine and caffeine).
- •2. have an established diagnosis of delirium according to DSM IV TR™ criteria.
- •3. are at imminent risk of self-harm or are at risk of harming to others.
- •4. have a score of 2 on any of items 7,10, or 11 on the Modified InterSePT scale for suicidal thinking (ISST).
- •5. have a score of 17 or below on Mini Mental State Examination (MMSE).
- •Medical Exclusion Criteria
- •1. have an uncontrolled, unstable clinically significant medical condition (eg, renal, hepatic, endocrine, respiratory, cardiovascular, metabolic, hematologic, immunologic, cerebrovascular disease, anorexia or obesity [body mass index (BMI) = 18.5 or >35] or malignancy), which, in the opinion of the investigator, may interfere with the interpretation of safety, efficacy, or pharmacokinetic evaluations. In case of BMI beyond the limits mentioned above, discussion should occur between the investigator and the sponsor before enrolling such subject(s) in the study.
- •2. have jaundice or total bilirubin of >2X upper limit of normal (ULN).
- •3. have any clinically significant abnormal laboratory, vital signs, physical examination, or electrocardiogram (ECG) findings at screening and any significant changes at randomization that, in the opinion of the investigator, precludes trial participation.
- •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 HIV antibody.
- •7. have a history of neuromalignant syndrome in the past 5 years.
- •8. have a life-time history of cerebrovascular accident (e.g., documented history of stroke or TIA’s).
- •9. have a history of myocardial infarction in past 5 years.
- •10. have Parkinson’s disease.
- •Medications
- •1. have been judged by the principal investigator to be medically noncompliant in the management of their disease.
- •2. have been judged by the principal investigator to be unable to reduce his or her daily benzodiazepine intake during inpatient phase to a maximum of 6 mg/day of lorazepam (or the equivalent dose of another short-acting benzodiazepine).
- •3. have been treated with clozapine in the previous 6 months;
- •4. have previously participated in an asenapine clinical trial.
- •5. have taken an investigational drug within 30 days prior to first dose (Day 1).
研究者
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