A Study of Olanzapine in Patients With Acute Agitation

NCT05803642 | Unknown Phase 3

• 1 other identifier: QLG2072-301
• Study Type: interventional
• Target: 318
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

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

  The PANSS-EC comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)

  2 hours

Secondary Outcomes (2)

• Percentage of Participants With 40% or Greater Percent Decrease in the PANSS-EC Total Score

  2 hours post-first IM injection

• Proportion of participants receiving one, two, or three doses of study drug during 24-hour intramuscular treatment period

  24 hours

Study Arms (2)

Olanzapine

EXPERIMENTAL

Drug: Olanzapine

Haloperidol

ACTIVE COMPARATOR

Drug: Haloperidol

Interventions

Olanzapine DRUG

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

Olanzapine

Haloperidol DRUG

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

Haloperidol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients with serious or unstable medical illnesses.
• Female patients who have a positive pregnancy test at screening or are breastfeeding.
• Patients who have participated in other clinical trials within 3 months before randomization.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Interventions

Olanzapine; Haloperidol

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Butyrophenones; Ketones; Organic Chemicals

Central Study Contacts

Gang Wang, PhD

CONTACT

010-58303236; adwanggang@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 7, 2023
• Study Start: March 28, 2023
• Primary Completion: May 7, 2024
• Study Completion: July 2, 2024
• Last Updated: April 7, 2023

Record last verified: 2023-03