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A Study of Olanzapine in Patients With Acute Agitation

NCT05803642 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2023-04-07

No results posted yet for this study

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

Interventions

DRUG

Olanzapine

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

DRUG

Haloperidol

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

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-28
Primary Completion
2024-05-07
Completion
2024-07-02

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05803642 on ClinicalTrials.gov