Acute Schizophrenia Episode Clinical Trial
Official title:
A Multicenter, Open-label Study to Evaluate the Effectiveness and Safety of Aripiprazole in Patients With Acute Episode of Schizophrenia
| Verified date | February 2021 |
| Source | Peking University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 770 |
| Est. completion date | February 2, 2021 |
| Est. primary completion date | January 23, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Anding Hospital, Capital Medical University | Beijing | Beijing |
| China | Beijing HuiLongGuan Hospital | Beijing | Beijing |
| China | Peking University Sixth Hospital | Beijing | Beijing |
| China | 102 Miltary Hospital of China | Changzhou | Jiangsu |
| China | The Fourth People's Hospital of Chengdu | Chengdu | Sichuan |
| China | The First Haerbin Psychiatric Hospital | Ha'erbin | Heilongjiang |
| China | Hangzhou Seventh People's Hospital | Hanzhou | Zhejiang |
| China | The Fourth People's Hospital of Hefei | Hefei | Anhui |
| China | Shandong Mental Health Center | Jinan | Shandong |
| China | Shanghai Mental Health Center | Shanghai | Shanghai |
| China | Wuhan Mental Health Center | Wuhan | Hubei |
| China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
| Lead Sponsor | Collaborator |
|---|---|
| Peking University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Fasting blood lipids | Levels of fasting blood lipids | baseline,4,8 weeks | |
| Other | Fasting blood glucose | Levels of fasting blood glucose | baseline, 4,8 weeks | |
| Other | Serum prolactin | Levels of serum prolactin | baseline, 4,8 weeks | |
| Other | BMI (body mass index) | weight and height will be combined to report BMI in kg/m^2 | baseline,1,2,4,8 weeks | |
| Other | Waist circumference | measurement of waist circumference in centimeters | baseline,1,2,4,8 weeks | |
| Other | Hip circumference | measurement of hip circumference in centimeters | baseline,1,2,4,8 weeks | |
| Other | Occurrence of adverse reactions | Occurrence of adverse reactions will be recorded | baseline,1,2,4,8 weeks | |
| Primary | 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 | |
| Primary | PANSS positive score | Change from baseline PANSS positive score at 8 weeks | baseline,8 weeks | |
| Primary | CGI-S (clinical general impression-severity) | Change from baseline CGI-S (clinical general impression-severity) at 8 weeks | baseline,8 weeks | |
| Secondary | PANSS negative score | Change from baseline PANSS negative score at 8 weeks | baseline,8 weeks | |
| Secondary | MSQ (Medication Satisfaction Questionnaire)score | MSQ score at each assessment time point | baseline,8 weeks |