The Effect of Sertindole on Sensory Gating and Cognition in Schizophrenic Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)
研究概览
简要总结
This study aims to investigate whether the atypical antipsychotic and mixed 5-HT2/D2 antagonist sertindole modulates or improves both subcortical and cortical information processing in schizophrenic patients who had not or insufficiently responded to previous antipsychotic medication. This goal shall be accomplished by investigating the effect of sertindole of both prepulse inhibition of the acoustic startle (PPI) and P50 suppression of auditory evoked potentials in schizophrenic patients. These effects shall be compared to the effect of risperidone and shall also be compared to untreated healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Schizophrenia according to DSM IV
- •Selected and treated in respect of the SPC (20 mg Serdolect max. and population at risk will be excluded)
排除标准
- •DSM IV Axis I disorders other than schizophrenia: Substance-dependence (excepting nicotine-dependence and substance-abuse), recent (2 months) DSM IV diagnosis according to DIA-X of a major affective, anxiety disorder, eating-disorder.
- •DSM IV Axis II disorders: Lifetime DSM IV diagnosis of personality disorder.
- •ECG: QTc-interval >450 msec.
- •Systolic blood pressure <100 mmHg
- •Bradycardia (Hf < 50/Min) und Arrhythmias
- •Hypokalemia or Hypomagnesemia
研究组 & 干预措施
1
Schizophrenic patients treated with sertindole
干预措施: Sertindole (Drug)
2
Schizophrenic patients treated with risperidone
干预措施: Risperidone (Drug)
结局指标
主要结局
sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)
时间窗: Before and six weeks after antipsychotic treatment
次要结局
- Cognitive performances(Before and six weeks after antipsychotic treatment)
- Psychopathology (PANSS rating)(Before and six weeks after antipsychotic treatment)