A Study of Olanzapine in Patients With Acute Agitation

A Multicenter, Randomized, Double-blind, Parallel-controlled Injection of Olanzapine in the Treatment of Acute Agitation Associated With Schizophrenia and Bipolar I Disorder.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Agitation
• Intervention / Treatment: Drug: Olanzapine; Drug: Haloperidol

• Study Type: Interventional
• Enrollment (Anticipated): 318
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Gang Wang, PhD; Phone Number: 010-58303236; Email: adwanggang@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Olanzapine	Drug: Olanzapine; intramuscular injection, 10 mg/dose, first dose and an optional second or third dose.
Active Comparator: Haloperidol	Drug: Haloperidol; intramuscular injection, 7.5 mg/dose, first dose and an optional second or third dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 28, 2023
• Primary Completion (Anticipated): May 7, 2024
• Study Completion (Anticipated): July 2, 2024

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Psychomotor Agitation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Dopamine Agents; Dopamine Antagonists; Anti-Dyskinesia Agents; Olanzapine; Haloperidol; Haloperidol decanoate
• Other Study ID Numbers: QLG2072-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No