Schizophrenia
Conditions
Interventions
experimental group:Aripiprazole Oral Solution
Sponsors
Beijing Anding Hospital affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
13 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Inpatients with acute schizophrenia; 2. Aged 13 to 65 years at the time of signing the informed consent; 3. Total score of Positive and Negative Symptoms Scale (PANSS) >= 70; 4. Subjects and/or their family members (legal guardian or agent) fully understand and understand the research content of this study and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who have serious or unstable cardiovascular, respiratory, nervous system (including epilepsy or obvious cerebrovascular diseases), kidney, liver, endocrine or immune system diseases are not suitable to participate in the study as determined by the investigator; 2. The levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT) or urea nitrogen (BUN) during screening were more than 2 times of the upper limit of normal values; 3. Clinically significant electrocardiogram (ECG) abnormalities, including prolonged QTC (male QTC >=450ms or female QTC >=470ms), congenital history of long QT syndrome; 4. Organic mental disorders, mental disorders caused by psychoactive substances or non-addictive substances, mental retardation and emotional disorders; 5. Patients with refractory schizophrenia, that is, patients who are currently or have been treated with two or more antipsychotic drugs with different compounds in sufficient quantities and a full course of treatment, but have failed to respond; 6. Previous history of serious suicide attempts or violent acts; 7. Have a history of alcohol or drug abuse in the last 12 months, or a history of dependence in the last 12 months; 8. Allergic to aripiprazole; 9. Those who did not respond to previous aripiprazole treatment; 10. Pregnant or planning to be pregnant or lactating; 11. Patients with or have suffered from antipsychotic malignant syndrome (NMS), tardive dyskinesia (TD) or severe extrapyramidal adverse reactions; 12. Those who have received ECT in the past 2 months; 13. Participated in or are participating in other clinical trials within one month prior to the start of the clinical trial; 14.Other circumstances that the investigator considers inappropriate to participate in this clinical study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global impression, CGI;Medication Satisfaction Questionnaire, MSQ;PANSS negative symptom subscale;PANSS positive symptom subscale;PANSS general psychopathology subscale; | — |
Primary
| Measure | Time frame |
|---|---|
| Positive And Negative Syndrome Scale, PANSS; | — |
Countries
China
Contacts
Public ContactWang Gang
Beijing Anding Hospital affiliated to Capital Medical University
Outcome results
None listed