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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Schizophrenia Episode
• Intervention / Treatment: Drug: Aripiprazole

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.

• Study Type: Interventional
• Enrollment (Actual): 770
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • The Fourth People's Hospital of Hefei
  • Beijing
    • Beijing, Beijing, China, 100096
      • Beijing HuiLongGuan Hospital
    • Beijing, Beijing, China, 100069
      • Beijing Anding Hospital, Capital Medical University
    • Beijing, Beijing, China, 100191
      • Peking University Sixth Hospital
  • Heilongjiang
    • Ha'erbin, Heilongjiang, China, 150056
      • The First Haerbin Psychiatric Hospital
  • Henan
    • Zhengzhou, Henan, China, 450052
      • the First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Wuhan Mental Health Center
  • Jiangsu
    • Changzhou, Jiangsu, China, 213003
      • 102 Miltary Hospital of China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Shandong Mental Health Center
  • Shanghai
    • Shanghai, Shanghai, China, 200003
      • Shanghai Mental Health Center
  • Sichuan
    • Chengdu, Sichuan, China, 610036
      • The Fourth People's Hospital of Chengdu
  • Zhejiang
    • Hanzhou, Zhejiang, China, 310013
      • Hangzhou Seventh People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: aripiprazole group; Patients receive aripiprazole treatment	Drug: 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.; Other Names: Aripiprazole Orally Disintegrating Tablets; Bosiqing®

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting blood lipids	Levels of fasting blood lipids	baseline,4,8 weeks
Fasting blood glucose	Levels of fasting blood glucose	baseline, 4,8 weeks
Serum prolactin	Levels of serum prolactin	baseline, 4,8 weeks
BMI (body mass index)	weight and height will be combined to report BMI in kg/m^2	baseline,1,2,4,8 weeks
Waist circumference	measurement of waist circumference in centimeters	baseline,1,2,4,8 weeks
Hip circumference	measurement of hip circumference in centimeters	baseline,1,2,4,8 weeks
Occurrence of adverse reactions	Occurrence of adverse reactions will be recorded	baseline,1,2,4,8 weeks

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): January 23, 2020
• Study Completion (Actual): February 2, 2021

Study Registration Dates

• First Submitted: September 17, 2017
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (Actual): September 20, 2017

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Aripiprazole; Acute schizophrenia episode; positive symptoms
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole
• Other Study ID Numbers: 320-57-1706-1101-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No