Schizophrenia
Conditions
Interventions
case series:Patients were treated according to the diagnosis and treatment guidelines for schizophrenia and the instructions for Aripiprazole oral solution, combined with the specific clinical symptom
Sponsors
Beijing Anding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Hospitalized patients with acute schizophrenia; 2. Aged 18 to 65 years; 3. The total score of the Positive and Negative Symptoms Scale (PANSS) >=70; 4. Subject and legal guardian fully understand and understand the research content of this study, and voluntarily sign the informed consent (both signed by subject and legal guardian).
Exclusion criteria
Exclusion criteria: 1. Patients with severe 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), and a history of congenital long QT syndrome; 4. Organic mental disorders, mental disorders caused by psychoactive substances or non-addictive substances, mental retardation and emotional disorders; 5. Refractory schizophrenia, that is, the current or past use of two or more different compounds of antipsychotic drugs after a sufficient amount of a full course of treatment in patients with failure; 6. History of serious suicide attempt or violent behavior; 7. History of alcohol or drug abuse in the past 12 months, and history of dependence in the past 12 months; 8. Allergic to aripiprazole; 9. Previous aripiprazole treatment did not respond; 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. Electroconvulsive therapy (ECT) in the past 2 months; 13. People who have participated in or are participating in other clinical trials within one month prior to the commencement of the clinical trial; 14. Other circumstances that the investigator considers inappropriate for participating in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total score of the Positive and Negative Symptoms Scale (PANSS) from baseline was studied; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of PANSS Positive Symptom Scale (PANSS-P) from baseline;Changes in PANSS Negative Symptom Scale (PANSS-N) from baseline from each visit;Changes in PANSS General Psychopathology Scale (PANSS GP) from baseline;Changes in PANSS total scores from baseline at all viewing points except the end point;Effective rate calculated by subtracted PANSS total score;Clinical efficacy general rating scale: CGI-S score changes and the percentage of patients with different scores;Clinical efficacy general scale: CGI-I score changes and the percentage of patients with different scores;Medication Satisfaction Questionnaire (MSQ); | — |
Countries
China
Contacts
Public ContactWang Gang
Beijing Anding Hospital, Capital Medical University
Outcome results
None listed