UnknownPhase 3

A Study of Olanzapine in Patients With Acute Agitation

318 participantsStarted 2023-03-28

Plain-language summary

The purpose of this study is to assess the efficacy and safety of intramuscular olanzapine for the treatment of acute agitation associated with schizophrenia and bipolar I mania.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Male and female patients between the ages of 18 to 65 years, inclusive.
✓. Patients who have met DSM-5 criteria for schizophrenia and bipolar I disorder.
✓. Patients who are judged to be clinically acutely agitated with a total score of ≥ 14 on the 5 items comprising the PANSS-EC and at least one individual item score≥ 4 immediately before randomization.

Exclusion criteria

✕. Patients with agitation caused by delirium, seizures, developmental delay, poisoning, etc., or withdrawal from drug abuse.
✕. Patients who have had previous suicidal behavior or currently at serious risk of suicide.
✕. Patients with glaucoma or at risk of angle-closure glaucoma.
✕. Patients who have brain diseases such as intracranial infection, brain trauma, cerebrovascular disease, basal ganglion disease, hypoxic encephalopathy, Parkinson's disease, Parkinson's syndrome, and dementia.
✕. Use of benzodiazepines, other hypnotics or short-acting antipsychotic drugs within 4 hours before randomization.
✕. Treatment with psychostimulants or reserpine within one week before randomization.
✕. Patients who received long-acting injections of typical or atypical antipsychotics within 2 weeks prior to randomization or within one injection interval.
✕. Treatment with clozapine within 4 weeks before screening.

What they're measuring

Change from baseline to 2 hours post-first IM injection on the PANSS-EC

Timeframe: 2 hours

Trial details

NCT IDNCT05803642

SponsorQilu Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-07

Contact for this trial

Gang Wang, PhD

010-58303236 adwanggang@163.com

View on ClinicalTrials.gov More Acute Agitation trials