A Multicenter, Open-label Study to Evaluate the Effectiveness and Safety of Aripiprazole in Patients With Acute Episode of Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 770
- 试验地点
- 12
- 主要终点
- CGI-S (clinical general impression-severity)
研究概览
简要总结
This study attempts to observe the effectiveness and safety of aripiprazole in hospitalized patients with acute schizophrenia episode, and to compare the different drug regimens that may be involved in order to clarify the characteristics of the population for taking aripiprazole and provide reference for clinical rational drug use.
详细描述
The control of acute schizophrenia effectively and rapidly will build up the confidence of patients on treatments. These early effects may influence the long-term compliance and prognosis of patients. Aripiprazole is an important drug in first line treatment of schizophrenia. However, at present in China, the application of aripiprazole in some patients with acute schizophrenia is not appropriate, leading to poor control of the positive symptoms of the acute phase.
The purpose of this single-arm, open-label trial is to study the situation of the use of aripiprazole in hospitalized patients with acute schizophrenia episode, and to compare the different drug regimens that may be involved in order to supply important information for optimizing treatment strategies of hospitalized patients characterized by positive symptom.
The hospitalized patients characterized by positive symptom with acute schizophrenia episode were recruited. At the time of enrollment, the demographic, symptomatic and laboratory data was collected. After the completion of the baseline assessment and examination, the patients were given aripiprazole. Clinical evaluation was performed at 1、2、4 and 8 weeks after treatment, including the therapeutic efficacy and adverse drug reactions ,and monitoring of laboratory data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients meeting International Classification of Diseases (tenth version, ICD-10) criteria for schizophrenia.
- •acute episode; inpatients
- •Age from 18-65 years old (inclusion), male or female
- •PANSS total score at least 70
- •scoring ≥ 4 on at least two of the following PANSS items: P1 (delusions), P2 (conceptual disorganisation), P3 (hallucinations), P6 (suspiciousness/persecution) ; and PANSS positive score is higher than PANSS negative score
- •Written informed consent
排除标准
- •other serious diseases;
- •Pregnant or breast feeding women or planning a pregnancy
- •Patients in a state of drug-induced malignant syndrome or serious extrapyramidal side effect, or with a history of malignant syndrome or serious extrapyramidal side effect;
- •Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- •Allergy to Aripiprazole
- •History of alcohol or drug abuse or dependence in the past 1-year before screening
- •mental retardation; bipolar disorder; major depressive disorder;
- •Currently using one kind of antipsychotic drug at a dose that exceeds the recommended maximum dose for two weeks, but no improvement in core symptoms; or currently using two kinds of antipsychotic drugs, at least one of which reaches or exceeds the recommended maximum dose for two weeks, but no improvement in core symptoms; or currently using three kinds of antipsychotic drugs or more;
- •Refractory schizophrenia patients who did not respond to treatments of two different type antipsychotics with adequate dose and course
- •Patients with clinically significant abnormalities on electrocardiogram or laboratory tests
- •Patients with clinically significant abnormalities on liver function (ALT or AST>2 times of higher limit of normal range)
- •Patients who had Electroconvulsive Therapy (ECT) in the past 2 months
- •Participation in a clinical trial of another drug within 4 weeks prior to study entry
研究组 & 干预措施
aripiprazole group
Patients receive aripiprazole treatment
干预措施: Aripiprazole (Drug)
结局指标
主要结局
CGI-S (clinical general impression-severity)
时间窗: baseline,8 weeks
Change from baseline CGI-S (clinical general impression-severity) at 8 weeks
PANSS (positive and negative symptoms scale) total score
时间窗: baseline,8 weeks
Change from baseline PANSS (positive and negative symptoms scale) total score at 8 weeks
PANSS positive score
时间窗: baseline,8 weeks
Change from baseline PANSS positive score at 8 weeks
次要结局
- MSQ (Medication Satisfaction Questionnaire)score(baseline,8 weeks)
- PANSS negative score(baseline,8 weeks)
研究者
Si Tianmei
Director of Clinical Psychopharmacology Division, Peking University Sixth Hospital
Peking University