The Monitor of Serum Prolactin Level and Related Clinical Observations Among Individuals With Schizophrenia Spectrum Illnesses in a 3 Months Aripiprazole Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- prolactin level drops after shifting to aripiprazole
研究概览
简要总结
A short term post-market monitoring of serum prolactin level change among patients with schizophrenia shifting from other antispychotics to different dosages of aripiprazole.
详细描述
This is an open-label clinical trial of adult inpatients or outpatients with a diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder as measured by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR). Eligible patients will have laboratory and clinical assessments completed. All procedures in this study are considered standard care and impose no additional risks to the patients. Participation is voluntary and recruitment will be on an "as come" basis.
Study Visits Schedule
Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Day -7 Day 7 Day 14 Day 21 Day 28 Day 90 Baseline Initiation Endpoint prolonged f/u
Discussion of Design and Control
Because of the ethical concerns regarding withholding medication from seriously ill patients, this study does not employ a washout period. Though patients may have their antipsychotic drug held for up to 12 hours, this should not present any clinical problems in the majority of patients. This one day prevalence trial allows for clinical data to be collected in a timely manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients may be included in the study if they meet the following criteria:
- •Males and females 16-65 years of age
- •Diagnosis of schizophrenia, schizoaffective or schizophreniform disorder
- •Each individual must have a level of understanding sufficient to perform all tests and examinations required
- •Individuals must be willing to fast after midnight the evening prior to study visit
- •Individuals must be willing to provide a small sample of blood for evaluation
- •Individuals must be willing to participate in a short 30-45 minute clinical interview
排除标准
- •Patients may be excluded from the study for any of the following reasons:
- •A current diagnosis of diabetes mellitus
- •Serious unstable illness such that death is anticipated within 1 year or intensive care unit hospitalization for the condition is anticipated within 6 months
- •Uncorrected hypothyroidism or hyperthyroidism
- •Uncorrected tumor secreting ectopic prolactinemia
结局指标
主要结局
prolactin level drops after shifting to aripiprazole
时间窗: 3 months
次要结局
- correlations between prolactin and other clinical outcomes(6 months)