acute agitation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 55 (including 18 and 55), male or female; (2) Hospitalized or In-patient patients with schizophrenia or bipolar disorder who meet the diagnosis defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); (3) At least two of the five items of excitement factor (P4), hostility (P7), nervousness (G4), non-cooperation (G8), and lack of impulse control (G14) of the baseline positive and negative symptom scale (PANSS-EC) were =4. (4)Written informed consent signed by the patient and legal guardian.
Exclusion criteria
Exclusion criteria: (1)Agitation caused by Delirium, Seizures, Developmental Delay, Intoxication, or withdrawal reactions from substance abuse; (2) Patients who had received a long-acting typical or atypical antipsychotic injection within 2 weeks prior to the first administration of the study drug (but who could then be reassessed for eligibility or exclusion);The situation of olanzapine administration for one week outside the hospital is unknown; (3) Female patients with positive pregnancy test or lactating at the time of screening; (4) Abnormal value was found in the laboratory examination or ECG examination of the patient, and the investigator considered the abnormal value to be clinically significant in this study; (5) Any history of major or unstable cardiovascular (including ischemic heart disease and congestive heart failure), respiratory, nervous system (including epilepsy or significant cerebrovascular disease), liver, kidney, endocrine or immune diseases, narrow-angle glaucoma; (6) Those who cannot take medicine as prescribed by the doctor; (7) Patients with a history of electroconvulsive therapy in the previous 2 weeks were randomly assigned.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ositive And Negative Syndrome Scale,PANSS;Clinical global impression; | — |
Countries
China
Contacts
Beijing Anding Hospital affiliated to Capital Medical University