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

NCT00650429 | Completed Phase 4

• 1 other identifier: A1281056
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline to endpoint in Brief Psychiatric Rating Scale (BPRS) total score

  Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)

Secondary Outcomes (12)

• Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale score

  Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)

• Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scale score

  Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)

• Simpson-Angus Scale (SAS)

  Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO)

• Barnes Akathisia Scale (BAS)

  Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO)

• Laboratory tests

  Screening and Week 6

Study Arms (1)

Arm A

EXPERIMENTAL

Drug: Ziprasidone

Interventions

Ziprasidone 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.

Also known as: Geodon, Zeldox

Arm A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (4)

Pfizer Investigational Site

Monterrey, Nuevo León, 64800, Mexico

Location

Pfizer Investigational Site

DF, 14420, Mexico

Location

Pfizer Investigational Site

Mexico City, 14050, Mexico

Location

Pfizer Investigational Site

Mexico D F, 14269, Mexico

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2008
• First Posted: April 1, 2008
• Study Start: October 1, 2003
• Study Completion: May 1, 2005
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

ME (4)