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

NCT ID: NCT03289026

Last Updated: 2021-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 770 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2021-02-02

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.

Conditions

Acute Schizophrenia Episode

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

aripiprazole group

Patients receive aripiprazole treatment

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

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.

Interventions

Aripiprazole

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.

Intervention Type: DRUG

Other Intervention Names

Aripiprazole Orally Disintegrating Tablets; Bosiqing®

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Si Tianmei

Director of Clinical Psychopharmacology Division, Peking University Sixth Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Fourth People's Hospital of Hefei

Hefei, Anhui, China

Beijing Anding Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing HuiLongGuan Hospital

Beijing, Beijing Municipality, China

Peking University Sixth Hospital

Beijing, Beijing Municipality, China

The First Haerbin Psychiatric Hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Wuhan Mental Health Center

Wuhan, Hubei, China

102 Miltary Hospital of China

Changzhou, Jiangsu, China

Shandong Mental Health Center

Jinan, Shandong, China

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

The Fourth People's Hospital of Chengdu

Chengdu, Sichuan, China

Hangzhou Seventh People's Hospital

Hanzhou, Zhejiang, China

Countries

China

Other Identifiers

320-57-1706-1101-0001

Identifier Type: -

Identifier Source: org_study_id