EUCTR2007-005772-13-HU进行中（未招募）不适用
Comparative efficacy of amisulpride vs. risperidone on cognitive functions in patients with chronic schizophrenia.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 102
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
- •1.Diagnosis: DSM-IV schizophrenia (any subtype)
- •2.Aged between 18 and 65 years
- •3.Sex: Male, or non pregnant female subjects
- •4.General Health: Satisfactory medical assessment with no clinically significant and relevant abnormalities
- •5.Duration of illness: = 5 years
- •6.Concomitant standing or prn medications (except other antipsychotics and those contraindicated in the respective package inserts [amisulpride or risperidone]) are permitted during treatment phase, if they were present at a stable dose for at least 6 weeks prior to the start of initial treatment with study medication
- •7.Overall symptom severity: patients must evidence a total score of 60 or higher on the PANSS scale
- •8.Clinical Symptoms: A score of 4 (moderate) or greater on any of the 7 items of the PANSS Positive Symptom Subscale (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility) is present
- •9.Cognitive status (minimum performance level): subject must be able to validly complete the baseline MATRICS assessment (validity of performance to be assessed by Chief Neuropsychologist or NP tester)
- •10.Clinical judgment by the investigator that treatments with amisulpride or risperidone are warranted due to suboptimal clinical outcome despite previous treatments
- •11.Patient is judged capable of understanding all relevant risks and potential benefits of the study and provides informed consent
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Past or current intolerance of amisulpride or risperidone side effects that are judged by the investigator to be unsafe, dose-limiting, or likely to result in study discontinuation.
- •2.Any contraindication for amisulpride or risperidone therapy as indicated in the drug description. (Contrainidications for amisulpride therapy: prolactine dependent tumours, phaeochromocytome, pregnant or breast feeding woman, creatinine-clearance<10 ml/min, combination with drugs are potential triggers for torsades de pointes and hypersensitivity / intolerance to the active substance or to any of the excipients. Contraindications for risperidone therapy: hypersensitivity / intolerance to the active substance or to any of the excipients.)
- •3.Presence of any unstable or untreated medical disorder.
- •4.Any history of seizures or seizure disorder other than febrile seizures of childhood;
- •5.History of positive hepatitis B surface antigen.
- •6.Any abnormal laboratory test that is judged to be clinically significant by the investigator.
- •7.A history of significant head injury/trauma, as defined by:
- •A.loss of consciousness (LOC) for more than 1 hour
- •B.recurring seizures resulting from the head injury
- •C.clear cognitive sequelae of the injury
- •D.cognitive rehabilitation following the injury
- •8.Alcohol or substance dependence within the past 12 months or abuse within the past 3 months. Any subject with positive urine toxicology or alcohol use that is considered abnormal at baseline.
- •9.Clinically significant suicidal or homicidal behavior or attempts within past 6 months.
- •10.Any subject who is judged by the investigator to present a danger to self or others.
- •11.Any subject who is judged by the investigator to be unable or unlikely to comply with all study requirements, including adherence with prescribed medication regimen.
- •12.Pregnant or breast-feeding women (excluded by pregnancy test)
- •13.Absence of medically approved contraceptive methods for female of childbearing potential.
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