A Study of the Efficacy and Safety of Ziprasidone for the Treatment of Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

NCT ID: NCT00650429

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2005-05-31

Brief Summary

This study was conducted to examine the efficacy and tolerability of ziprasidone intramuscular (IM), and to assess the effect of switching from IM to oral ziprasidone for the treatment of acute exacerbation of schizophrenia and schizoaffective disorder in a Latin American population.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

Group Type: EXPERIMENTAL

Ziprasidone

Intervention Type: DRUG

IM ziprasidone at an initial dose of 10 or 20 mg for the first 3 days; additional doses could be administered according to clinical need, with the maximum total daily IM dose of 40 mg. On Day 4, IM treatment was switched to oral (PO) treatment at an initial dose of 40 mg twice daily for the first 2 days; doses could be subsequently adjusted within the range of 40 to 80 mg twice daily. Total treatment duration was 6 weeks.

Interventions

Ziprasidone

IM ziprasidone at an initial dose of 10 or 20 mg for the first 3 days; additional doses could be administered according to clinical need, with the maximum total daily IM dose of 40 mg. On Day 4, IM treatment was switched to oral (PO) treatment at an initial dose of 40 mg twice daily for the first 2 days; doses could be subsequently adjusted within the range of 40 to 80 mg twice daily. Total treatment duration was 6 weeks.

Intervention Type: DRUG

Other Intervention Names

Geodon, Zeldox

Eligibility Criteria

Inclusion Criteria

• Diagnosis of schizophrenia or schizoaffective disorder.
• Inpatients with acute exacerbation of psychotic symptoms.
• Patients with a minimum score of 40 on the BPRS scale (1-7).

Exclusion Criteria

• Concurrent treatment with antipsychotic agents at study drug initiation (within 12 hours prior to study drug initiation); for depot agents a period of two weeks or one cycle, whichever is the longer, must occur between last administration and study drug initiation.
• Treatment with antidepressants or mood stabilizers within 7 days of start of ziprasidone.
• Patients currently receiving clozapine.
• Patients at immediate risk of committing harm to self or others.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Investigational Site

Monterrey, Nuevo León, Mexico

Pfizer Investigational Site

DF, , Mexico

Pfizer Investigational Site

Mexico City, , Mexico

Pfizer Investigational Site

Mexico D F, , Mexico

Countries

Mexico

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281056&StudyName=A%20study%20of%20the%20efficacy%20and%20safety%20of%20ziprasidone%20for%20the%20treatment%20of%20acute%20exacerbation%20of%20schizophrenia%20or%20schizoaffective%20disorder

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Other Identifiers

A1281056

Identifier Type: -

Identifier Source: org_study_id