Naturalistic Prospective Follow-Up of Patients With Schizophrenia or Bipolar Disorders Receiving Atypical Antipsychotics and/or Mood Stabilizers
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of long-term psychopharmacotherapy in schizophrenia or bipolar disorder in terms of psychopathology and side effects.
详细描述
Schizophrenia and bipolar disorder are renowned for chronic and deteriorating course. Although atypical antipsychotics and mood stabilizers are widely used as treatment of choice for these illness based on acute efficacy and safety, long-term efficacy and safety of these agents are still open to debate. Prospective follow-up study in naturalistic condition may be a useful way of elucidating cons and pros of long-term psychopharmacotherapy.In this study, efficacy and various side effects of drugs will be measured, and the possibility of neurophysiological markers will be tested by serial measurements of electroencephalographic changes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female patients, 18-65 years of age.
- •Patients must have a diagnosis of schizophrenia or bipolar disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
- •Patients have not been received antipsychotics or mood stabilizers within the past 4 weeks prior to the study entry.
- •Each patient must provide written informed consent after full explanation of study protocol, and authorized legal guardian must understand the nature of the study and must also give assent to study participation.
排除标准
- •History of taking antipsychotics or mood stabilizers within past 4 weeks.
- •History of DSM-IV substance dependence.
- •Mental retardation (IQ < 70)or patients who are not able to understand the informed consent.
- •Definite or suspected organic mental disorders.
- •Female patients who are not able to maintain contraception during this study
- •Laboratory abnormalities with clinical significance
- •History of epilepsy or electroconvulsive therapy within the past 3 months.