Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aripiprazole group | Experimental | Patients receive aripiprazole treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | 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. |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth People's Hospital of Hefei | Hefei | Anhui | 230000 | China | ||
| Beijing Anding Hospital, Capital Medical University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| baseline,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 |
| Beijing |
| Beijing Municipality |
| 100069 |
| China |
| Beijing HuiLongGuan Hospital | Beijing | Beijing Municipality | 100096 | China |
| Peking University Sixth Hospital | Beijing | Beijing Municipality | 100191 | China |
| The First Haerbin Psychiatric Hospital | Harbin | Heilongjiang | 150056 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Wuhan Mental Health Center | Wuhan | Hubei | 430000 | China |
| 102 Miltary Hospital of China | Changzhou | Jiangsu | 213003 | China |
| Shandong Mental Health Center | Jinan | Shandong | 250014 | China |
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | 200003 | China |
| The Fourth People's Hospital of Chengdu | Chengdu | Sichuan | 610036 | China |
| Hangzhou Seventh People's Hospital | Hanzhou | Zhejiang | 310013 | China |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |