Clinical trial NCT03289026: Pharmacologic Treatment of Acute Episode of Schizophrenia: a Real World Study
Official title: A Multicenter, Open-label Study to Evaluate the Effectiveness and Safety of Aripiprazole in Patients With Acute Episode of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Schizophrenia Episode
Keywords: Aripiprazole; Acute schizophrenia episode; positive symptoms
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2017-09-20
Enrollment: 770
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: PANSS (positive and negative symptoms scale) total score
timeFrame: baseline,8 weeks
measure: PANSS positive score
timeFrame: baseline,8 weeks
measure: CGI-S (clinical general impression-severity)
timeFrame: baseline,8 weeks
Secondary outcomes:
measure: PANSS negative score
timeFrame: baseline,8 weeks
measure: MSQ (Medication Satisfaction Questionnaire)score
timeFrame: baseline,8 weeks
Other outcomes:
measure: Fasting blood lipids
timeFrame: baseline,4,8 weeks
measure: Fasting blood glucose
timeFrame: baseline, 4,8 weeks
measure: Serum prolactin
timeFrame: baseline, 4,8 weeks
measure: BMI (body mass index)
timeFrame: baseline,1,2,4,8 weeks
measure: Waist circumference
timeFrame: baseline,1,2,4,8 weeks
measure: Hip circumference
timeFrame: baseline,1,2,4,8 weeks
measure: Occurrence of adverse reactions
timeFrame: baseline,1,2,4,8 weeks
Locations:
city: Hefei
country: China
facility: The Fourth People's Hospital of Hefei
state: Anhui
city: Beijing
country: China
facility: Beijing Anding Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing HuiLongGuan Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Sixth Hospital
state: Beijing
city: Ha'erbin
country: China
facility: The First Haerbin Psychiatric Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Wuhan Mental Health Center
state: Hubei
city: Changzhou
country: China
facility: 102 Miltary Hospital of China
state: Jiangsu
city: Jinan
country: China
facility: Shandong Mental Health Center
state: Shandong
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
city: Chengdu
country: China
facility: The Fourth People's Hospital of Chengdu
state: Sichuan
city: Hanzhou
country: China
facility: Hangzhou Seventh People's Hospital
state: Zhejiang
Study officials:
References: