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

Primary Purpose

Acute Schizophrenia Episode

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Schizophrenia Episode focused on measuring Aripiprazole; Acute schizophrenia episode; positive symptoms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Fourth People's Hospital of Hefei
  • Beijing Anding Hospital, Capital Medical University
  • Beijing HuiLongGuan Hospital
  • Peking University Sixth Hospital
  • The First Haerbin Psychiatric Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Wuhan Mental Health Center
  • 102 Miltary Hospital of China
  • Shandong Mental Health Center
  • Shanghai Mental Health Center
  • The Fourth People's Hospital of Chengdu
  • Hangzhou Seventh People's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

aripiprazole group

Arm Description

Patients receive aripiprazole treatment

Outcomes

Primary Outcome Measures

PANSS (positive and negative symptoms scale) total score
Change from baseline PANSS (positive and negative symptoms scale) total score at 8 weeks
PANSS positive score
Change from baseline PANSS positive score at 8 weeks
CGI-S (clinical general impression-severity)
Change from baseline CGI-S (clinical general impression-severity) at 8 weeks

Secondary Outcome Measures

PANSS negative score
Change from baseline PANSS negative score at 8 weeks
MSQ (Medication Satisfaction Questionnaire)score
MSQ score at each assessment time point

Full Information

First Posted
September 17, 2017
Last Updated
February 3, 2021
Sponsor
Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT03289026
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
January 23, 2020 (Actual)
Study Completion Date
February 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Schizophrenia Episode
Keywords
Aripiprazole; Acute schizophrenia episode; positive symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
770 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aripiprazole group
Arm Type
Experimental
Arm Description
Patients receive aripiprazole treatment
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Aripiprazole Orally Disintegrating Tablets; Bosiqing®
Intervention Description
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.
Primary Outcome Measure Information:
Title
PANSS (positive and negative symptoms scale) total score
Description
Change from baseline PANSS (positive and negative symptoms scale) total score at 8 weeks
Time Frame
baseline,8 weeks
Title
PANSS positive score
Description
Change from baseline PANSS positive score at 8 weeks
Time Frame
baseline,8 weeks
Title
CGI-S (clinical general impression-severity)
Description
Change from baseline CGI-S (clinical general impression-severity) at 8 weeks
Time Frame
baseline,8 weeks
Secondary Outcome Measure Information:
Title
PANSS negative score
Description
Change from baseline PANSS negative score at 8 weeks
Time Frame
baseline,8 weeks
Title
MSQ (Medication Satisfaction Questionnaire)score
Description
MSQ score at each assessment time point
Time Frame
baseline,8 weeks
Other Pre-specified Outcome Measures:
Title
Fasting blood lipids
Description
Levels of fasting blood lipids
Time Frame
baseline,4,8 weeks
Title
Fasting blood glucose
Description
Levels of fasting blood glucose
Time Frame
baseline, 4,8 weeks
Title
Serum prolactin
Description
Levels of serum prolactin
Time Frame
baseline, 4,8 weeks
Title
BMI (body mass index)
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
baseline,1,2,4,8 weeks
Title
Waist circumference
Description
measurement of waist circumference in centimeters
Time Frame
baseline,1,2,4,8 weeks
Title
Hip circumference
Description
measurement of hip circumference in centimeters
Time Frame
baseline,1,2,4,8 weeks
Title
Occurrence of adverse reactions
Description
Occurrence of adverse reactions will be recorded
Time Frame
baseline,1,2,4,8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
The Fourth People's Hospital of Hefei
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Facility Name
Beijing Anding Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100069
Country
China
Facility Name
Beijing HuiLongGuan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100096
Country
China
Facility Name
Peking University Sixth Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
The First Haerbin Psychiatric Hospital
City
Ha'erbin
State/Province
Heilongjiang
ZIP/Postal Code
150056
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Wuhan Mental Health Center
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
102 Miltary Hospital of China
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Facility Name
Shandong Mental Health Center
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China
Facility Name
The Fourth People's Hospital of Chengdu
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610036
Country
China
Facility Name
Hangzhou Seventh People's Hospital
City
Hanzhou
State/Province
Zhejiang
ZIP/Postal Code
310013
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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