A Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis

An Open, Multicenter, Non-Comparative Study To Assess The Efficacy And Tolerability Of Intramuscular Ziprasidone Followed By Oral Ziprasidone In Patients With Acute Psychosis

To assess the efficacy, safety, and tolerability of intramuscular ziprasidone in the treatment of the acute exacerbation of non-organic psychosis of any etiology, including schizophrenia, acute mania, delusional disorder and others.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Mania; Delusional Disorder; Acute Exacerbation of Psychosis
• Intervention / Treatment: Drug: Ziprasidone

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Bahia
    • Salvador, Bahia, Brazil, 41180-000
      • Pfizer Investigational Site
  • Ceara
    • Fortaleza, Ceara, Brazil, 60175-270
      • Pfizer Investigational Site
  • MG
    • Belo Horizonte, MG, Brazil, 30150-270
      • Pfizer Investigational Site
  • PR
    • Curitiba, PR, Brazil
      • Pfizer Investigational Site
  • RJ
    • Rio de Janeiro, RJ, Brazil
      • Pfizer Investigational Site
    • Sao Goncalo, RJ, Brazil
      • Pfizer Investigational Site
  • SP
    • Sao Paulo, SP, Brazil
      • Pfizer Investigational Site
  • Salvador - BA
    • Jardim Santa Monica SN, Salvador - BA, Brazil, 40340-720
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hospitalized patients with psychosis
• Eligible for intramuscular treatment
• Miminum score of 60 on the PANSS, a score of 14 in the sum of PANSS excitation score and a score of at least 4 in 1 of the following items: poor control of impulses, tension, hostility, uncooperativeness or excitation.

Exclusion Criteria:

• Treatment with antidepressants or mood stabilizers within seven days prior to the enrollment; for monoamine oxidase inhibitors (MAOIs) and moclobemide, this period must be two weeks; for fluoxetine, five weeks
• Resistance to conventional antipsychotic agents
• A history of epilepsy
• A diagnosis of abuse of substance within the previous 3 months according to the DSMIV criteria.

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; Intramuscular ziprasidone 10 or 20 mg at the investigator's discretion for 1 to 3 days followed by oral ziprasidone capsules 40 to 80 mg twice daily at the investigator's discretion to complete 7 days of treatment; Other Names: Geodon, Zeldox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Positive and Negative Syndrome Scale (PANSS) excitation items scores	Days 1-3 (end of intramuscular dosing)

Secondary Outcome Measures

Outcome Measure	Time Frame
Electrocardiogram at Visits 1 and 5	Visits 1 (Screening) and 5 (Day 7)
Adverse events at Visits 2, 3, 4, and 5	Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)
Change from baseline in Patient Preference Scale (PPS) scores at Visits 3 and 5	Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4) and 5 (Day 7)
Laboratory tests at Visits 1 and 5	Visits 1 (Screening) and 5 (Day 7)
Movement disorder rating scale scores (Barnes Akathisia Scale and Extrapyramidal Symptoms Rating Scale) at Visits 2, 3, 4, and 5	Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)
Change from baseline in PANSS excitation items scores at Visits 3, 4, and 5	Visits 1 (Screening), 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)
Blood pressure and pulse at Visits 1, 2, and 5	Visits 1 (Screening), 2 (Day 1), and 5 (Day 7)
Change from baseline in Clinical Global Impression-Severity (CGI-S) scores at Visits 3, 4, and 5	Visits 1 (Screening), 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)

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: July 1, 2003
• Study Completion (Actual): May 1, 2004

Study Registration Dates

• First Submitted: March 20, 2008
• First Submitted That Met QC Criteria: March 20, 2008
• First Posted (Estimate): March 27, 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: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders; Schizophrenia, Paranoid; 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: A1281074