Psychomotor agitation associated with mental disorders
Conditions
Interventions
Haloperidol Injection Group:Administration of haloperidol injection
Olanzapine Injection Group:Administration of olanzapine injection
Sponsors
Shandong mental health center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Patients with mental disorders who are in an acute state of agitation, as assessed by a licensed psychiatrist, with a Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) score >= 14 before randomization, and a score =4 on at least one of the five PANSS-EC items; 2.Written informed consent has been obtained from the patient and/or their legal guardian.
Exclusion criteria
Exclusion criteria: 1. Agitation caused by medical conditions such as epilepsy, brain developmental disorders, or intoxication, or agitation caused by withdrawal from substance dependence, such as alcohol, amphetamines, or cocaine; 2. Patients with glaucoma or those at risk of angle-closure glaucoma; 3. Patients with brain disorders, including intracranial infection, traumatic brain injury, cerebrovascular disease, basal ganglia disease, intracranial space-occupying lesions, hypoxic encephalopathy, Parkinson's disease, parkinsonism, dementia, or other relevant brain diseases; 4. Patients with known QT interval prolongation, defined as QTc >=450 ms in men or >=470 ms in women at screening/baseline, congenital long QT syndrome, decompensated heart failure, or a history of ventricular arrhythmia or torsades de pointes; 5. Patients with severe or unstable medical conditions requiring urgent treatment at screening; 6. Patients who have received intramuscular antipsychotic treatment within 4 hours before randomization; 7. Patients who have received psychostimulants or reserpine within 1 week before randomization; 8. Patients who have received long-acting injectable typical or atypical antipsychotics within 2 weeks before randomization or within one dosing interval, whichever is longer; 9. Patients who have received electroconvulsive therapy (ECT) or modified electroconvulsive therapy (MECT) within 2 weeks before screening, or who are expected to require ECT/MECT during the study treatment period; 10. Patients who have received systemic treatment with clozapine within 2 weeks before screening; 11. Patients who have previously received olanzapine or haloperidol and are considered to have had an inadequate response to olanzapine or haloperidol, or patients whose washout period before randomization is less than five drug half-lives; 12. Patients with an allergic predisposition, or with a history of hypersensitivity or intolerance to olanzapine, haloperidol, their excipients, or related compounds; 13. Patients with a previous or current history of severe or unstable cardiovascular diseases, such as acute myocardial infarction, unstable angina, congestive heart failure, severe hypotension and/or bradycardia, or sick sinus syndrome, or severe or unstable respiratory, endocrine, metabolic, hepatic, renal, dermatologic, malignant, hematologic, neurological, or immune system diseases, which, in the investigator's judgment, may affect participation in the study; 14. Patients with current seizures or a history of epilepsy; 15. Patients with laboratory test results at screening showing ALT or AST >2 times the upper limit of normal, based on the reference range of the study site laboratory; an absolute neutrophil count <1,000/mm^3, namely 1.0 × 10^9/L; or other clinically significant abnormal findings that, in the investigator's judgment, make the patient unsuitable for enrollment; 16. Female patients who are pregnant at screening, have a positive urine pregnancy test, or are breastfeeding; 17. Patients who have participated in another clinical trial within 2 months before randomization; 18. Patients who, in the investigator's judgment, have any other condition that makes them unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| Other safety outcomes, including the incidence of adverse events (AEs), electrocardiographic parameters, and vital signs;Changes in hematological and biochemical parameters;Minimum number of days required for marked improvement in agitation;Between-group comparison of changes in scale scores;Duration of effect after a single dose; | — |
Countries
China
Contacts
Public ContactXu Chen
Shandong mental health center
Outcome results
None listed