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

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ClinicalTrials.gov Identifier: NCT03289026
Recruitment Status : Not yet recruiting
First Posted : September 20, 2017
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Si Tianmei, Peking University

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.

Condition or disease Intervention/treatment Phase
Acute Schizophrenia Episode Drug: Aripiprazole Phase 4

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  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label Study to Evaluate the Effectiveness and Safety of Aripiprazole in Patients With Acute Episode of Schizophrenia
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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 Name: Aripiprazole Orally Disintegrating Tablets; Bosiqing®




Primary Outcome Measures :
  1. PANSS (positive and negative symptoms scale) total score [ Time Frame: baseline,8 weeks ]
    Change from baseline PANSS (positive and negative symptoms scale) total score at 8 weeks

  2. PANSS positive score [ Time Frame: baseline,8 weeks ]
    Change from baseline PANSS positive score at 8 weeks

  3. CGI-S (clinical general impression-severity) [ Time Frame: baseline,8 weeks ]
    Change from baseline CGI-S (clinical general impression-severity) at 8 weeks


Secondary Outcome Measures :
  1. PANSS negative score [ Time Frame: baseline,8 weeks ]
    Change from baseline PANSS negative score at 8 weeks

  2. MSQ (Medication Satisfaction Questionnaire)score [ Time Frame: baseline,8 weeks ]
    MSQ score at each assessment time point


Other Outcome Measures:
  1. Fasting blood lipids [ Time Frame: baseline,4,8 weeks ]
    Levels of fasting blood lipids

  2. Fasting blood glucose [ Time Frame: baseline, 4,8 weeks ]
    Levels of fasting blood glucose

  3. Serum prolactin [ Time Frame: baseline, 4,8 weeks ]
    Levels of serum prolactin

  4. BMI (body mass index) [ Time Frame: baseline,1,2,4,8 weeks ]
    weight and height will be combined to report BMI in kg/m^2

  5. Waist circumference [ Time Frame: baseline,1,2,4,8 weeks ]
    measurement of waist circumference in centimeters

  6. Hip circumference [ Time Frame: baseline,1,2,4,8 weeks ]
    measurement of hip circumference in centimeters

  7. Occurrence of adverse reactions [ Time Frame: baseline,1,2,4,8 weeks ]
    Occurrence of adverse reactions will be recorded



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289026


Contacts
Contact: Tianmei Si, PhD. 861062723748 si.tian-mei@163.com

Locations
China, Anhui
The Fourth People's Hospital of Hefei Not yet recruiting
Hefei, Anhui, China, 230000
Contact: Jianliang Gao, MD.    8617756065210    793354604@qq.com   
China, Beijing
Beijing Anding Hospital, Capital Medical University Not yet recruiting
Beijing, Beijing, China, 100069
Contact: Yang Yang, MD.    8613581528424    271558711@qq.com   
Beijing HuiLongGuan Hospital Not yet recruiting
Beijing, Beijing, China, 100096
Contact: Shaoxiao Yan, MD.    861062715511    393831968@qq.com   
Peking University Sixth Hospital Not yet recruiting
Beijing, Beijing, China, 100191
Contact: Tianmei Si, PhD.    861062723748    si.tian-mei@163.com   
China, Heilongjiang
The First Haerbin Psychiatric Hospital Not yet recruiting
Ha'erbin, Heilongjiang, China, 150056
Contact: Jia Xu, MD.    86045182404870    xujiaxujia132129@sina.com   
China, Henan
The First Affiliated Hospital of Zhengzhou University Not yet recruiting
Zhengzhou, Henan, China, 450052
Contact: Shuying Li, PhD.    8613525520821    lishuying6112@126.com   
China, Hubei
Wuhan Mental Health Center Not yet recruiting
Wuhan, Hubei, China, 430000
Contact: Maosheng Fang, MD.    8613553013182    fangmaosheng@126.com   
China, Jiangsu
102 Miltary Hospital of China Not yet recruiting
Changzhou, Jiangsu, China, 213003
Contact: Haiying Yu, MD.    86051983064711    cpyhy_102@163.com   
China, Shandong
Shandong Mental Health Center Not yet recruiting
Jinan, Shandong, China, 250014
Contact: Jintong Liu, MD.    86053186336610    jintongliu@sdu.edu.cn   
China, Shanghai
Shanghai Mental Health Center Not yet recruiting
Shanghai, Shanghai, China, 200003
Contact: Peifen Yao, MD.    8602164387250    ypf93@163.com   
China, Sichuan
The Fourth People's Hospital of Chengdu Not yet recruiting
Chengdu, Sichuan, China, 610036
Contact: Mingjun Duan, MD.    8618980717307    316437342@qq.com   
China, Zhejiang
Hangzhou Seventh People's Hospital Not yet recruiting
Hanzhou, Zhejiang, China, 310013
Contact: Zhiyu Chen, MD.    86057185129503    hzczy536@163.com   
Sponsors and Collaborators
Peking University

Responsible Party: Si Tianmei, Director of Clinical Psychopharmacology Division, Peking University Sixth Hospital, Peking University
ClinicalTrials.gov Identifier: NCT03289026     History of Changes
Other Study ID Numbers: 320-57-1706-1101-0001
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Si Tianmei, Peking University:
Aripiprazole; Acute schizophrenia episode; positive symptoms

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs