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Trial record 17 of 410 for:    ARIPIPRAZOLE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03289026
Recruitment Status : Recruiting
First Posted : September 20, 2017
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
Si Tianmei, Peking University

Tracking Information
First Submitted Date  ICMJE September 17, 2017
First Posted Date  ICMJE September 20, 2017
Last Update Posted Date December 13, 2019
Actual Study Start Date  ICMJE September 1, 2017
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2017)
  • 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
  • PANSS positive score [ Time Frame: baseline,8 weeks ]
    Change from baseline PANSS positive score at 8 weeks
  • CGI-S (clinical general impression-severity) [ Time Frame: baseline,8 weeks ]
    Change from baseline CGI-S (clinical general impression-severity) at 8 weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03289026 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2017)
  • PANSS negative score [ Time Frame: baseline,8 weeks ]
    Change from baseline PANSS negative score at 8 weeks
  • MSQ (Medication Satisfaction Questionnaire)score [ Time Frame: baseline,8 weeks ]
    MSQ score at each assessment time point
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 18, 2017)
  • Fasting blood lipids [ Time Frame: baseline,4,8 weeks ]
    Levels of fasting blood lipids
  • Fasting blood glucose [ Time Frame: baseline, 4,8 weeks ]
    Levels of fasting blood glucose
  • Serum prolactin [ Time Frame: baseline, 4,8 weeks ]
    Levels of serum prolactin
  • 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
  • Waist circumference [ Time Frame: baseline,1,2,4,8 weeks ]
    measurement of waist circumference in centimeters
  • Hip circumference [ Time Frame: baseline,1,2,4,8 weeks ]
    measurement of hip circumference in centimeters
  • Occurrence of adverse reactions [ Time Frame: baseline,1,2,4,8 weeks ]
    Occurrence of adverse reactions will be recorded
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Pharmacologic Treatment of Acute Episode of Schizophrenia: a Real World Study
Official Title  ICMJE A Multicenter, Open-label Study to Evaluate the Effectiveness and Safety of Aripiprazole in Patients With Acute Episode of Schizophrenia
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Schizophrenia Episode
Intervention  ICMJE 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®
Study Arms  ICMJE Experimental: aripiprazole group
Patients receive aripiprazole treatment
Intervention: Drug: Aripiprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 18, 2017)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tianmei Si, PhD. 861062723748 si.tian-mei@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03289026
Other Study ID Numbers  ICMJE 320-57-1706-1101-0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Si Tianmei, Peking University
Study Sponsor  ICMJE Peking University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Peking University
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP