NCT00554658已完成4 期
Quetiapine Induced Neuroplasticity in Schizophrenic Patients: A Combined Transcranial Magnetic Stimulation (TMS) and Voxel-based Morphometry (VBM) Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change of structural neuroplasticity (i.e. change in gray matter density) under treatment with quetiapine assessed by voxel-based morphometry.
研究概览
简要总结
Aim of the study is to assess the effect of quetiapine treatment in neuroleptic naive, first-episode schizophrenic patients on aspects of functional and structural neuroplasticity assessed by means of transcranial magnetic stimulation and voxel-based morphometry. Main outcome measure is a change in gray matter density under quetiapine treatment from baseline to steady-state-treatment after 3 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of first episode of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV) criteria and no history of neuroleptic medication
- •Females and/or males aged 18 to 65 years
- •Mild to moderate schizophrenia
排除标准
- •Neuroleptic treatment prior to study enrollment
- •Pregnancy or lactation
- •Any DSM-IV Axis I disorder not defined in the inclusion criteria
- •Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- •Known intolerance or lack of response to quetiapine fumarate as judged by the investigator
- •Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
- •Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
- •Any history of neuroleptic treatment
- •Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
- •Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrollment
- •Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- •Unstable or inadequately treated medical illness (e.g. angina pectoris, hypertension, congestive heart failure) as judged by the investigator
- •Involvement in the planning and conduct of the study
- •History of or evidence of significant brain malformation or neoplasm, head injury, cerebral vascular events, neurodegenerative disorder affecting the brain or prior brain surgery
- •Concomitant treatment with psychotropic drugs (e.g. antidepressive agents, anticonvulsants, other neuroleptics) except benzodiazepines or hypnotics
研究组 & 干预措施
A
Active Comparator
Patients will be taken quetiapine for the treatment of first episode schizophrenia.
干预措施: Quetiapine (Drug)
结局指标
主要结局
Change of structural neuroplasticity (i.e. change in gray matter density) under treatment with quetiapine assessed by voxel-based morphometry.
时间窗: 3 weeks
次要结局
- Change of functional neuroplasticity (i.e. cortical excitability) under quetiapine treatment assessed by paired-pulse TMS(3 weeks)
- To evaluate the influence of BDNF gene polymorphisms on clinical effects of quetiapine treatment, cortical excitability and brain morphology(3 weeks)
研究者
Goeran Hajak
Prof. Dr. med.
University of Regensburg
研究点 (1)
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