Quetiapine induced neuroplasticity in schizophrenic patients: A combined TMS and VBM study

Medical Institutions of the District Oberpfalz/Bayern (MedBO GmbH)0 个研究点开始时间: 2007年9月12日最近更新: 2013年5月20日

试验速览

暂无简介。

•- Provision of written informed consent
•- A 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
•- 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
•- Mild to moderate schizophrenia
•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

•- Neuroleptic treatment prior to study enrolment
•- Pregnancy or lactation
•- Any DSM-IV Axis I disorder not defined in the inclusion criteria
•- Known intolerance or lack of response to quetiapine fumarate as judged by the investigator
•- Substance or alcohol dependence at enrolment (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 enrolment
•- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
•- History of or evidence of significant brain malformation or neoplasm, head injury, cerebral vascular events, neurodegenerative disorder affecting the brain or prior brain surgery
•- Unstable or inadequately treated medical illness (e.g. angina pectoris, hypertension, congestive heart failure) as judged by the investigator
•- Concomitant treatment with psychotropic drugs (e.g. antidepressive agents, anticonvulsants, other neuroleptics) except benzodiazepines or hypnotics
•- Cardiac pace makers, other electronic implants, intracranial metallic particles
•- History of seizures or epileptiform activity
•- An absolute neutrophil count (ANC) of £1.5 x 109 per liter.
•- Unstable Diabetes mellitus/HbA1c

发起方

Medical Institutions of the District Oberpfalz/Bayern (MedBO GmbH)