Status:
COMPLETED
Pharmacologic Treatment of Acute Episode of Schizophrenia: a Real World Study
Lead Sponsor:
Peking University
Conditions:
Acute Schizophrenia Episode
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 i...
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2021
Estimated Enrollment :
770 Patients enrolled
Trial Details
Trial ID
NCT03289026
Start Date
September 1 2017
End Date
February 2 2021
Last Update
February 5 2021
Active Locations (12)
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1
The Fourth People's Hospital of Hefei
Hefei, Anhui, China, 230000
2
Beijing Anding Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100069
3
Beijing HuiLongGuan Hospital
Beijing, Beijing Municipality, China, 100096
4
Peking University Sixth Hospital
Beijing, Beijing Municipality, China, 100191