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Application of Olanzapine population pharmacokinetic model in acute agitation

Application of Olanzapine population pharmacokinetic model in acute agitation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073922
Enrollment
Unknown
Registered
2023-07-25
Start date
2021-06-11
Completion date
Unknown
Last updated
2023-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute agitation

Interventions

Model group:Model group was given 5mg of olanzapine orally on the first day, and fasting blood sampling was performed on the second morning to check blood drug concentration. According to the patient
Control group:In the control group, 5mg olanzapine was taken on the first day, 5mg was added daily, and the dosage was gradually increased to 20mg olanzapine daily.

Sponsors

Beijing Anding Hospital affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

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

MeasureTime frame
ositive And Negative Syndrome Scale,PANSS;Clinical global impression;

Countries

China

Contacts

Public ContactFeifeiWang

Beijing Anding Hospital affiliated to Capital Medical University

892069644@qq.com+86 188 1178 0559

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026