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Completed

NCT Number: NCT00650429

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Monterrey, Nuevo León, Mexico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Geodon, Zeldox

Primary outcomes

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

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

Secondary outcomes

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

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

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

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

  3. Simpson-Angus Scale (SAS)

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

  4. Barnes Akathisia Scale (BAS)

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

  5. Laboratory tests

    Time frame: Screening and Week 6

  6. Electrocardiogram

    Time frame: Screening and Week 6

  7. Adverse events

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

  8. Abnormal Involuntary Movement Scale (AIMS)

    Time frame: Day 1 (IM), Day 4 (Switch), and Week 6 (PO)

  9. Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total score

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

  10. Change from baseline to endpoint in Covi Anxiety Scale score

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

  11. Change from baseline to endpoint in Positive PANSS subscale score

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

  12. Change from baseline to endpoint in Negative PANSS subscale score

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

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2005
First posted
Apr 1, 2008
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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