A Study of Olanzapine in Patients With Acute Agitation

NCT ID: NCT05803642

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 318 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-28
• Study Completion Date: 2024-07-02

Brief 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.

Conditions

Acute Agitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Olanzapine

Group Type: EXPERIMENTAL

Olanzapine

Intervention Type: DRUG

intramuscular injection, 10 mg/dose, first dose and an optional second or third dose.

Haloperidol

Group Type: ACTIVE_COMPARATOR

Haloperidol

Intervention Type: DRUG

intramuscular injection, 7.5 mg/dose, first dose and an optional second or third dose.

Interventions

Olanzapine

intramuscular injection, 10 mg/dose, first dose and an optional second or third dose.

Intervention Type: DRUG

Haloperidol

intramuscular injection, 7.5 mg/dose, first dose and an optional second or third dose.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male and female patients between the ages of 18 to 65 years, inclusive.

2. Patients who have met DSM-5 criteria for schizophrenia and bipolar I disorder.

3. 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

1. Patients with agitation caused by delirium, seizures, developmental delay, poisoning, etc., or withdrawal from drug abuse.

2. Patients who have had previous suicidal behavior or currently at serious risk of suicide.

3. Patients with glaucoma or at risk of angle-closure glaucoma.

4. 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.

5. Use of benzodiazepines, other hypnotics or short-acting antipsychotic drugs within 4 hours before randomization.

6. Treatment with psychostimulants or reserpine within one week before randomization.

7. Patients who received long-acting injections of typical or atypical antipsychotics within 2 weeks prior to randomization or within one injection interval.

8. Treatment with clozapine within 4 weeks before screening.

9. Patients with serious or unstable medical illnesses.

10. Female patients who have a positive pregnancy test at screening or are breastfeeding.

11. Patients who have participated in other clinical trials within 3 months before randomization.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Gang Wang, PhD

Role: CONTACT

adwanggang@163.com

010-58303236

Other Identifiers

QLG2072-301

Identifier Type: -

Identifier Source: org_study_id