EUCTR2006-003560-62-BG进行中（未招募）不适用
A Randomized, Double-Blind, Parallel-Group, Comparative Study of FlexibleDoses of Paliperidone Palmitate and Flexible Doses of Risperidone Long-ActingIntramuscular Injection in Subjects with Schizophrenia
Janssen-Cilag International N.V., Turnhoutseweg 30, 2340 Beerse, Belgium0 个研究点目标入组 1,050 人开始时间: 2008年4月18日最近更新:
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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
- 1,050
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
- •Men or women, aged at least 18 years old or the minimum age to provide
- •informed consent in the jurisdiction in which the study is taking place,
- •whichever is greater
- •Meet diagnostic criteria for schizophrenia according to DSM-IV
- •(disorganized type [295.10], catatonic type [295.20], paranoid type
- •[295.30], residual type [295.60], or undifferentiated type [295.90]) for at
- •least 1 year before screening
- •A total PANSS score between 60 and 120, inclusive, at screening and
- •Body mass index (BMI) at the screening visit BMI .17 kg/m2
- •Female subjects must be postmenopausal for at least 2 years, surgically
- •sterile, abstinent, or, if sexually active, be practicing an effective method
- •of birth control before study entry and throughout the study. Effective
- •methods of birth control include contraceptive pills, coil, depot injection
- •of gestagen, subdermal implantation, hormonal vaginal ring, and
- •transdermal depot patches. Women of childbearing potential must have a
- •negative serum beta-human chorionic gonadotropin (ß-hCG) pregnancy
- •test result at screening.
- •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
- •Unable to provide their own consent or involuntarily committed to
- •psychiatric hospitalization
- •A primary, active DSM-IV diagnosis on Axis I other than schizophrenia
- •A DSM-IV diagnosis of active substance dependence within 3 months
- •before screening (nicotine and caffeine are not exclusionary)
- •History of treatment resistance as defined by failure to respond to
- •2 adequate treatments with different antipsychotic medications (an
- •adequate treatment is defined as a minimum of 6 weeks at maximum
- •tolerated dosage)
- •Relevant history or current presence of any significant or unstable
- •cardiovascular, respiratory, neurologic (including seizures or significant
- •cerebrovascular disease), renal, hepatic, hematologic, endocrine,
- •immunologic, morbid obesity (BMI >40 kg/m2), or other systemic disease
- •History of any severe pre-existing gastrointestinal narrowing (pathologic
- •or iatrogenic) or inability to swallow oral study drug whole with the aid of
- •water (applies to those subjects requiring oral tolerability only)
- •Serum chemistry, hematology, or urinalysis results that are not within the
- •laboratory’s normal reference range and are deemed to be clinically
- •significant by the investigator
- •History or evidence of clinically significant hepatic disease [including
- •aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
- •>2 times the upper limit of normal] at screening
- •History of neuroleptic malignant syndrome (NMS)
- •Significant risk of suicidal or violent behavior, as clinically assessed by
- •the investigator
- •Subjects who have participated in 2 or more clinical trials in the past year,
- •or in 1 clinical trial in the past 6 months (non-intervention, observational,
- •and retrospective studies excluded)
- •History of any active malignancy within previous 5 years, with the exception of basal cell carcinomas.
- •Women who are pregnant or nursing, or is planning to become pregnant during the trial.
- •Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of the investigator or study center, as well as family members of the employees or the investigator
- •History of disallowed therapies:
- •An injectable antipsychotic within 1 injection interval before screening.
- •clozapine within 3 months before baseline
- •Risperidone LAI injection within 6 weeks before screeningprevious injection of paliperidone palmitate within past 10 months
- •Electroconvulsive therapy (ECT) within 60 days before screening
- •Nonselective/irreversible MAOI antidepressants within 30 days before screening
- •The following types of medications are not permitted during the double blind and should be washed out by Day –1, (protocol guideline for washout is 5 times the elimination half life):
- •Mood stabilizers, including lithium and all anticonvulsants
- •Antiparkinsonian medication
- •Beta Blockers
- •other prescription, OTC or herbal agents with psychoactive properties
- •History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death in association with the use of drugs that prolong the QTc interval, including:
- •Heart rate <50 beats per minute
- •Demonstration of repeated prolonged QTc Fridericia interval >450 ms,as measured on more than one ECG (either during screening, or from prior medical records)
- •The following cardiac conditions: sick sinus syndrome, complete atrioventricular block, congestive heart failure, polymorphic ventricular tachycardia
- •Clinically relevant hypocalcemia, hypokalem
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