EUCTR2006-003560-62-ES进行中（未招募）1 期
A Randomized, Double-Blind, Parallel-Group, Comparative Study of FlexibleDoses of Paliperidone Palmitate and Flexible Doses of Risperidone Long-ActingIntramuscular Injection in Subjects with SchizophreniaEstudio Comparativo, Aleatorizado, Doble-Ciego, de Grupos Paralelos entre Diferentes Dosis de Palmitato de Paliperidona y de Risperidona Intramuscular Inyectable de Larga Duración en Sujetos con Esquizofrenia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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)
研究者
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