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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00650429
• Other study ID #: A1281056
• Status: Completed
• Phase: Phase 4
• Start date: October 2003
• Est. completion date: May 2005

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Ziprasidone
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.

Locations

Country	Name	City	State
Mexico	Pfizer Investigational Site	DF
Mexico	Pfizer Investigational Site	Mexico City
Mexico	Pfizer Investigational Site	Mexico D F
Mexico	Pfizer Investigational Site	Monterrey	Nuevo LEON

Sponsors (1)

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

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to endpoint in Brief Psychiatric Rating Scale (BPRS) total score		Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Secondary	Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale score		Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Secondary	Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scale score		Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Secondary	Simpson-Angus Scale (SAS)		Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO)
Secondary	Barnes Akathisia Scale (BAS)		Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO)
Secondary	Laboratory tests		Screening and Week 6
Secondary	Electrocardiogram		Screening and Week 6
Secondary	Adverse events		Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Secondary	Abnormal Involuntary Movement Scale (AIMS)		Day 1 (IM), Day 4 (Switch), and Week 6 (PO)
Secondary	Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total score		Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Secondary	Change from baseline to endpoint in Covi Anxiety Scale score		Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Secondary	Change from baseline to endpoint in Positive PANSS subscale score		Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
Secondary	Change from baseline to endpoint in Negative PANSS subscale score		Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)

External Links

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