EUCTR2007-000479-40-DE进行中（未招募）不适用
Effects of quetiapine on ultrastructural hippocampal and neurochemical changes in patients with bipolar disorder: searching for the antidepressant and mood stabilising neurophysiology
Department of Psychiatry, RWTH Aachen0 个研究点开始时间: 2009年2月26日最近更新:
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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
- •Provision of written informed consent
- •A diagnosis of bipolar disorder by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV); patients only (n=20)
- •No current or history of psychiatric disorder by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV); healthy controls only (n=20)
- •Females and males, aged 18-55 years
- •Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment
- •Able to understand and comply with the requirements of the study; IQ of at least 85 (estimated by MWT-B)
- •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.Pregnancy or lactation
- •2.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: (P450 3A4 inhibitors) 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
- •Use of (cytochrome P450) inducers 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and glucocorticoids
- •depot antipsychotic injection within one dosing interval (for the depot) before randomisation
- •Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
- •Use of Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
- •Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- •Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
- •An absolute neutrophil count (ANC) of ?1.5 x 109 per liter
- •Involvement in the planning and conduct of the study
- •Previous enrolment or randomisation of treatment in the present study.
- •Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
- •The usual MR-criteria apply. Persons with electrical (such as cardiac pulse generator) or metal implants, backache, heavy overweight, metallic tattoos or pregnancy are excluded.
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