A Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Arm A
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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:
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Outcome Measures
Primary Outcome Measures
- Change from baseline in Positive and Negative Syndrome Scale (PANSS) excitation items scores [Days 1-3 (end of intramuscular dosing)]
Secondary Outcome Measures
- 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)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Hospitalized patients with psychosis
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Eligible for intramuscular treatment
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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:
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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
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Resistance to conventional antipsychotic agents
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A history of epilepsy
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A diagnosis of abuse of substance within the previous 3 months according to the DSMIV criteria.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Pfizer Investigational Site | Salvador | Bahia | Brazil | 41180-000 |
2 | Pfizer Investigational Site | Fortaleza | Ceara | Brazil | 60175-270 |
3 | Pfizer Investigational Site | Belo Horizonte | MG | Brazil | 30150-270 |
4 | Pfizer Investigational Site | Curitiba | PR | Brazil | |
5 | Pfizer Investigational Site | Rio de Janeiro | RJ | Brazil | |
6 | Pfizer Investigational Site | Sao Goncalo | RJ | Brazil | |
7 | Pfizer Investigational Site | Jardim Santa Monica SN | Salvador - BA | Brazil | 40340-720 |
8 | Pfizer Investigational Site | Sao Paulo | SP | Brazil |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A1281074