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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

376 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-07-31

Brief Summary

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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

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Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intramuscular ziprasidone

Group Type EXPERIMENTAL

Intramuscular ziprasidone mesylate

Intervention Type DRUG

The recommended dose is 10 to 20 mg administered as required up to a maximum dose of 40 mg per day. Doses of 10 mg may be administered every two hours; doses of 20 mg may be administered every four hours up to a maximum of 40 mg/day for 3 days.

Intramuscular haloperidol

Group Type ACTIVE_COMPARATOR

Intramuscular haloperidol

Intervention Type DRUG

The haloperidol group will receive an initial intramuscular injection of haloperidol 5mg, following on which 5mg haloperidol may be repeated every 4-8 hours to a maximum of 20 mg /day for 3 days.

Interventions

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Intramuscular ziprasidone mesylate

The recommended dose is 10 to 20 mg administered as required up to a maximum dose of 40 mg per day. Doses of 10 mg may be administered every two hours; doses of 20 mg may be administered every four hours up to a maximum of 40 mg/day for 3 days.

Intervention Type DRUG

Intramuscular haloperidol

The haloperidol group will receive an initial intramuscular injection of haloperidol 5mg, following on which 5mg haloperidol may be repeated every 4-8 hours to a maximum of 20 mg /day for 3 days.

Intervention Type DRUG

Other Intervention Names

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Zeldox, Geodon Haldol

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No