The Effect of Lamictal TM Augmentation of Haloperidol Decanoate in the Treatment of Resistant Schizophrenia Predominantly by Verbal Resistant Hallucinosis: Randomized, Double-blind, Placebo-controlled, Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 335
- 试验地点
- 1
- 主要终点
- Data suggest that haloperidol decanoate with the combination of lamotrigine was more effective than placebo.
研究概览
简要总结
The purpose of this study is to determine the effect of lamotrigine augmentation of Haloperidol decanoate in the treatment of Resistant Schizophrenia predominantly by verbal resistant hallucinosis: A randomized, double-blind, placebo-controlled, study.
Nadir A.Aliyev & Zafar N.Aliyev
Central Mental Clinic for Outpatients of Baku city of Azerbaijan Republic
Abstract:
OBJECTIVE: The current paper reports on a double-blind, randomized study of the role of lamotrigine as an augmentation agent to haloperidol decanoate in the treatment of out patient's schizophrenia with verbal resistant hallucinosis.
详细描述
METHOD:A structured clinical interview, for DSM-IV Axis I Disorder, Patient Edition, was used to diagnose schizophrenia according to DSM-IV. Three hundred fifty patients were studied. The patients were then randomly divided into two groups on 175 subjects in each group. First group patients received either haloperidol deaconate 50 mg in weekly intramuscular and lamotrigine 150-200 mg in day per so for 12 weeks. Second group patients were given haloperidol deaconate 50 mg in weekly intramuscular and placebo per os for 12 weeks. Data for clinical assessments were collected at weeks 0, 6 and 12 weeks. The expressiveness of psychopathology was estimated on PANSS. Test response in both groups was defined as a reduction in the PANSS by using analysis of variance and chi-square tests.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age from 18-60;
- •both gender;
- •resistant scizophrenia patients;
- •previous treatment history;
- •verbal resistant hallucinosis.
排除标准
- 未提供
研究组 & 干预措施
Starch
In these study participants are randomly (by chance) assigned for two treatment arms of a clinical trial.
干预措施: Lamictal TM (Drug)
Starch
In these study participants are randomly (by chance) assigned for two treatment arms of a clinical trial.
干预措施: Haloperidol Decanoate (Drug)
结局指标
主要结局
Data suggest that haloperidol decanoate with the combination of lamotrigine was more effective than placebo.
时间窗: 2006
次要结局
- lamotrigine augmentation of haloperidol decanoate improve treatment-resistant schizophrenia(2007)