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Completed

NCT Number: NCT00644800

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

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Key information

Conditions

Schizophrenia Acute Exacerbation of Psychosis Delusional Disorder Mania Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia, Paranoid Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Fortaleza, Ceará, Brazil

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Ziprasidone

Drug

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

Primary outcomes

  1. Change from baseline in Positive and Negative Syndrome Scale (PANSS) excitation items scores

    Time frame: Days 1-3 (end of intramuscular dosing)

Secondary outcomes

  1. Electrocardiogram at Visits 1 and 5

    Time frame: Visits 1 (Screening) and 5 (Day 7)

  2. Adverse events at Visits 2, 3, 4, and 5

    Time frame: Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)

  3. Change from baseline in Patient Preference Scale (PPS) scores at Visits 3 and 5

    Time frame: Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4) and 5 (Day 7)

  4. Laboratory tests at Visits 1 and 5

    Time frame: Visits 1 (Screening) and 5 (Day 7)

  5. Movement disorder rating scale scores (Barnes Akathisia Scale and Extrapyramidal Symptoms Rating Scale) at Visits 2, 3, 4, and 5

    Time frame: Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)

  6. Change from baseline in PANSS excitation items scores at Visits 3, 4, and 5

    Time frame: Visits 1 (Screening), 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)

  7. Blood pressure and pulse at Visits 1, 2, and 5

    Time frame: Visits 1 (Screening), 2 (Day 1), and 5 (Day 7)

  8. Change from baseline in Clinical Global Impression-Severity (CGI-S) scores at Visits 3, 4, and 5

    Time frame: Visits 1 (Screening), 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7)

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2004
First posted
Mar 27, 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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