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临床试验/NCT01939093
NCT01939093已完成4 期

Therapeutic Effect Between Quetiapine and Haloperidol on the Treatment of Methamphetamine - Induced Psychosis

Chulalongkorn University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
80
试验地点
1
主要终点
Positive and Negative Syndrome Scale

研究概览

简要总结

The aims of this study are to compare the antipsychotic and adverse events of quetiapine, an atypical antipsychotic drug, to haloperidol, a standard treatment for primary psychotic disorder, in individuals with MAP.

详细描述

Eighty individuals with MAP will be randomly assigned into two treatment groups, i.e. treatment with quetiapine and haloperidol. The quetiapine group will receive quetiapine at least 100 mg per day and the haloperidol group will receive haloperidol at least 2 mg per day orally once a day for four weeks. The doses will be increased every 5 days until no psychotic symptom is observed from the Positive and Negative Syndrome Scale. Common antipsychotic adverse events will be checked and documented daily.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having a psychotic episode with current use of methamphetamine
  • Positive urine toxicology test for methamphetamine on the first day of hospitalization

排除标准

  • Using other illegal substances
  • Having a history of primary psychotic disorders or using antipsychotic agents
  • Having a chronic medical disease, e.g. essential hypertension, diabetes, epilepsy, stroke

研究组 & 干预措施

Quetiapine

Experimental

Quetiapine 100 mg per day is taken orally once a day for four weeks. The dose is increased every 5 days until no psychotic symptom is observed.

干预措施: Diazepam (Drug)

Quetiapine

Experimental

Quetiapine 100 mg per day is taken orally once a day for four weeks. The dose is increased every 5 days until no psychotic symptom is observed.

干预措施: Vitamin B1-6-12 (Dietary Supplement)

Quetiapine

Experimental

Quetiapine 100 mg per day is taken orally once a day for four weeks. The dose is increased every 5 days until no psychotic symptom is observed.

干预措施: Stugeron (Drug)

Haloperidol

Active Comparator

Haloperidol 2 mg per day is taken orally once a day for four weeks. The dose is increased every 5 days until no psychotic symptom is observed.

干预措施: Diazepam (Drug)

Haloperidol

Active Comparator

Haloperidol 2 mg per day is taken orally once a day for four weeks. The dose is increased every 5 days until no psychotic symptom is observed.

干预措施: Vitamin B1-6-12 (Dietary Supplement)

Haloperidol

Active Comparator

Haloperidol 2 mg per day is taken orally once a day for four weeks. The dose is increased every 5 days until no psychotic symptom is observed.

干预措施: Stugeron (Drug)

结局指标

主要结局

Positive and Negative Syndrome Scale

时间窗: Every two days in Week 2 and 3.

次要结局

  • Antipsychotic Adverse Event Form(Every day for three weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rasmon Kalayasiri

Assistant Professor

Chulalongkorn University

研究点 (1)

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