Clozapine or Haloperidol in First Episode Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Brief Psychiatric Rating Scale
研究概览
简要总结
This study will examine the physical responses brought on by clozapine and haloperidol in people experiencing their first episode of schizophrenia.
详细描述
This is a longitudinal double blind, 2- 5 year study of the clinical, neuroendocrine and biochemical response to clozapine (CLOZ) and haloperidol (HAL) in a group of "first episode" schizophrenic (RDC) patients. Within the protocol, we compare the differential effects of the two drugs over the short term (12 weeks) and the long-term (2-5 years); we evaluate the relationship between change in prolactin level and clinical response of the patients; and we search for biochemical predictors and correlates of clinical response. To achieve the study aims, we employ a drug-washout period, a 12-week acute treatment period; and an 88 - 260 week follow-up period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RDC diagnosis of schizophrenia
- •Men and women, without regard to race/ethnicity,
- •Aged 18-45
- •Acutely psychotic with a score of at least 3 on one of the psychotic scale items of the Brief Psychiatric Rating Scale (BPRS) (hallucinations, delusions, conceptual disorganization) and a total BPRS of > 21 (on a 0 - 6 scale);
- •Require treatment with neuroleptic drugs on a clinical basis;
- •The patient (or the patient's authorized legal representative) must understand the nature of the study and sign the informed consent;
- •Be within the first episode of a psychotic disorder;
- •Have a history of neuroleptic treatment of < 12 weeks;
- •Likely to remain in the study for 2 years.
排除标准
- •Substance dependence in the last six months
- •History of seizure or blood dyscrasia
- •Major medical illness
- •Pregnancy or Lactation
研究组 & 干预措施
Clozapine
Clozapine 12.5-300 mg taken orally per day for 12 weeks in the acute phase of the study and up to 130 weeks (total) in the Follow-up portion of the study.
干预措施: Clozapine (Drug)
Haloperidol
Haloperidol 2-12 mg taken orally per day for 12 weeks in the acute phase of the study and up to 130 weeks (total) in the Follow-up portion of the study.
干预措施: Haloperidol (Drug)
结局指标
主要结局
Brief Psychiatric Rating Scale
时间窗: Weekly during the Acute Treatment Phase and every two weeks in Follow-Up
This study will use the 24 item BPRS
次要结局
未报告次要终点
研究者
AlanGreen
Chair, Department of Psychiatry Geisel School of Medicine at Dartmouth
Harvard Medical School (HMS and HSDM)