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

Schizophrenia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644800
• Other study ID #: A1281074
• Status: Completed
• Phase: Phase 4
• Start date: July 2003
• Est. completion date: May 2004

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Exacerbation of Psychosis
• Delusional Disorder
• Mania
• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Schizophrenia, Paranoid

Intervention

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

Locations

Country	Name	City	State
Brazil	Pfizer Investigational Site	Belo Horizonte	MG
Brazil	Pfizer Investigational Site	Curitiba	PR
Brazil	Pfizer Investigational Site	Fortaleza	Ceara
Brazil	Pfizer Investigational Site	Jardim Santa Monica SN	Salvador - BA
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Brazil	Pfizer Investigational Site	Salvador	Bahia
Brazil	Pfizer Investigational Site	Sao Goncalo	RJ
Brazil	Pfizer Investigational Site	Sao Paulo	SP

Sponsors (1)

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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Positive and Negative Syndrome Scale (PANSS) excitation items scores		Days 1-3 (end of intramuscular dosing)
Secondary	Electrocardiogram at Visits 1 and 5		Visits 1 (Screening) and 5 (Day 7)
Secondary	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)
Secondary	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)
Secondary	Laboratory tests at Visits 1 and 5		Visits 1 (Screening) and 5 (Day 7)
Secondary	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)
Secondary	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)
Secondary	Blood pressure and pulse at Visits 1, 2, and 5		Visits 1 (Screening), 2 (Day 1), and 5 (Day 7)
Secondary	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)

External Links

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