Investigation of the NMDA Receptor System in Man as a Potential Surrogate Marker for Deficit Syndrome in Schizophrenia: a [123]I-CNS 1261 Single Photon Emission Tomography (SPET) Study
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- CNS (Central Nervous System) 1261 binding differences in healthy volunteers and 3 different predefined subgroups of schizophrenic patients and in the 3 different subgroups of schizophrenic patients.
研究概览
简要总结
This study was designed to compare the [123]I-CNS 1261 binding to NMDA receptor between healthy volunteers and different subgroups of schizophrenic patients. Investigation of the potential influence of antipsychotic and concomitant medication on [123I] CNS 1261 binding is also relevant.Fifteen healthy subjects (male and female of non-child bearing potential) will be recruited and 40 schizophrenic patients divided in 3 subgroups as indicated before: Subgroup a) treatment-naive, (n=10); Subgroup b) on stable treatment with risperidone (without criteria of deficit syndrome on the SDS scale, (n=15);Subgroup c) on stable treatment with risperidone fitting criteria of deficit syndrome on the SDS scale, (n=15).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Right-handed
- •Healthy volunteer or schizophrenic patients as diagnosed by DSM IV criteria.
- •Treatment naive patients or with Risperidone treatment for 2 months that have not received any depot neuroleptic during the last year.
- •Women of childbearing potential must agree to acceptable method of birth control.
排除标准
- •Any clinically or laboratory significant abnormality.
- •Subjects receiving a radiation dose from other activities of more than 10 mSv over any 3 year period.
- •Heart pacemaker, metallic prosthesis or other metallic body implants.
- •History or presence of CNS conditions.
- •History of substance dependence.
- •History of or suffers from claustrophobia.
- •Positive test for HBV (hepatitis B virus), HCV (hepatitis C virus) or HIV.
- •Pregnant or lactating women.
结局指标
主要结局
CNS (Central Nervous System) 1261 binding differences in healthy volunteers and 3 different predefined subgroups of schizophrenic patients and in the 3 different subgroups of schizophrenic patients.
时间窗: throughout the study
次要结局
- Effect of treatment with risperidone and lorazepam in inducing changes on [123]I CNS 1261 binding, and its relationship with the plasma concentration of administered drugs and with Psychopathological scales scores.(throughout the study)