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

Ziprasidone Intramuscular/Oral In The Treatment Of Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder: A Six-Week Open Administration Study

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Drug: Ziprasidone

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 4

Contacts and Locations

Study Locations

• Mexico
  • DF, Mexico, 14420
    • Pfizer Investigational Site
  • Mexico City, Mexico, 14050
    • Pfizer Investigational Site
  • Mexico D F, Mexico, 14269
    • Pfizer Investigational Site
  • Nuevo LEON
    • Monterrey, Nuevo LEON, Mexico, 64800
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Arm A

Drug: 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.; Other Names: Geodon, Zeldox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Electrocardiogram	Screening and Week 6
Adverse events	Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Abnormal Involuntary Movement Scale (AIMS)	Day 1 (IM), Day 4 (Switch), and Week 6 (PO)
Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total 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 Covi Anxiety 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 Positive PANSS subscale 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 Negative PANSS subscale score	Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Study Completion (Actual): May 1, 2005

Study Registration Dates

• First Submitted: March 28, 2008
• First Submitted That Met QC Criteria: March 28, 2008
• First Posted (Estimate): April 1, 2008

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Ziprasidone
• Other Study ID Numbers: A1281056