EUCTR2008-001128-30-HU进行中（未招募）不适用
EFFICACY OF SERTINDOLE AS COMPARED TO OLANZAPINE OR RISPERIDONE ON PREATTENTIONAL AND ATTENTION-DEPENDENT FUNCTIONS IN PATIENTS WITH CHRONIC SCHIZOPHRENIA. A COGNITIVE AND FMRI STUDY. -
SE Dept. of Psychiatry and Psychotherapy0 个研究点开始时间: 2008年3月5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
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
- •Inclusion Criteria
- •- Diagnosis: DSM-IV schizophrenia (any subtype).
- •- Age: 18-65 years.
- •- Sex: Male, or non pregnant female subjects
- •- General Health: Satisfactory medical assessment with no clinically significant and relevant abnormalities.
- •- Duration of illness: >5 years
- •- Concomitant standing or prn medications (except other antipsychotics and those contraindicated in the respective package inserts) are permitted during all treatment phases, if they were present at a stable dose for at least 6 weeks prior to the start of initial treatment with study medication.
- •- Overall symptom severity: patients must evidence a total score of 60 or higher on the PANSS scale
- •- 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).
- •- Cognitive status (minimum performance level): subject must be able to validly complete the baseline RBANS assessment (validity of performance to be assessed by Chief Neuropsychologist or NP tester).
- •- Clinical judgment by the investigator that treatments with Sertindole, Olanzapine or Risperidone are warranted due to suboptimal clinical outcome despite previous treatments
- •- 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
- •Exclusion criteria
- •- Past or current intolerance of Sertindole, Olanzapine or Risperidone side effects that are judged by the investigator to be unsafe, dose-limiting, or likely to result in study discontinuation.
- •- Any contraindication for Sertindole, Olanzapine or Risperidone therapy as indicated in the drug description.
- •- Presence of any unstable or untreated medical disorder.
- •- Any history of seizures or seizure disorder other than febrile seizures of childhood;
- •- History of positive hepatitis B surface antigen.
- •- Any abnormal laboratory test that is judged to be clinically significant by the investigator.
- •- A history of significant head injury/trauma, as defined by:
- •- loss of consciousness for more than 1 hour
- •- recurring seizures resulting from the head injury
- •- clear cognitive sequelae of the injury
- •- cognitive rehabilitation following the injury
研究者
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