A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation

Viatris

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Intramuscular haloperidol; Drug: Intramuscular ziprasidone mesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00723606

A1281152

Details and patient eligibility

About

This local registration study is to confirm the hypothesis of the efficacy, tolerability and safety of ziprasidone IM (intramuscular) in the Chinese population with agitation in schizophrenia

Enrollment: 376 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female Chinese subjects aged 18-65 years (including 65) at screening.
• Subjects meeting the ICD-10 (Classification of Mental and Behavioral Disorders) criteria for schizophrenia (F20.X).
• Subjects who are in acute phase of schizophrenia and are appropriate to receive intramuscular medication for at least 3 days

Exclusion criteria

• History of clinically significant physical illness especially myocardial infarction, non compensatory heart failure etc.
• Subjects receiving an investigational agent in the previous 3 months prior to screening.
• Use of antipsychotic agents within 12 hours or parenteral benzodiazepines within 4 hours prior to randomization and during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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376 participants in 2 patient groups

Intramuscular ziprasidone

Experimental group

Treatment:

Drug: Intramuscular ziprasidone mesylate

Intramuscular haloperidol

Active Comparator group

Treatment:

Drug: Intramuscular haloperidol