Pharmacologic Treatment of Acute Episode of Schizophrenia: a Real World Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multicenter, Open-label Study to Evaluate the Effectiveness and Safety of Aripiprazole in Patients With Acute Episode of Schizophrenia

Conditions
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Acute Schizophrenia Episode

Intervention / Treatment
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* Drug: Aripiprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aripiprazole group<br>Patients receive aripiprazole treatment | Drug: Aripiprazole<br>* Doses were flexibly titrated to between 10 and 30 mg once daily based on the individual needs of the patient as determined by the investigator.<br>* Other names: Aripiprazole Orally Disintegrating Tablets; Bosiqing®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PANSS (positive and negative symptoms scale) total score | Change from baseline PANSS (positive and negative symptoms scale) total score at 8 weeks | baseline,8 weeks | 
| PANSS positive score | Change from baseline PANSS positive score at 8 weeks | baseline,8 weeks | 
| CGI-S (clinical general impression-severity) | Change from baseline CGI-S (clinical general impression-severity) at 8 weeks | baseline,8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PANSS negative score | Change from baseline PANSS negative score at 8 weeks | baseline,8 weeks | 
| MSQ (Medication Satisfaction Questionnaire)score | MSQ score at each assessment time point | baseline,8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aripiprazole; Acute schizophrenia episode; positive symptoms