A Study of the Efficacy and Safety of Ziprasidone in Patients With Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

Schizophrenia Clinical Trial

Official title:

Efficacy And Safety Of Ziprasidone In Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder, Including Patients With A Diagnosis Of Recent Onset

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00645229
• Other study ID #: A1281055
• Status: Terminated
• Phase: Phase 3
• Start date: September 2004
• Est. completion date: March 2005

Study information

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

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of ziprasidone in acute exacerbation of schizophrenia or schizoaffective disorder, including patients with recent onset of symptoms

Description:

The study was prematurely discontinued due to the difficulty of subject recruitment on March 24, 2005. There were no safety concerns that led to the decision to terminate.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients not currently being treated with antipsychotic medication and neuroleptic naive patients

• Diagnosis of schizophrenia or schizoaffective disorder

• Antipsychotic treatment prior to screening was to be for a cumulative period of less than 5 years

Exclusion Criteria:

• Patients at immediate risk of committing harm to self or others

• Treatment with clozapine within 3 months prior to baseline

• History of neuroleptic treatment

• Current antipsychotic treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Ziprasidone
Ziprasidone 20 mg capsules twice daily on Days 1-3; dose could be increased if clinically indicated up to 80 mg twice daily; total treatment duration was to be 24 weeks

Locations

Country	Name	City	State
Portugal	Pfizer Investigational Site	Lisboa

Sponsors (1)

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

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 24		Week 24
Primary	Change from baseline in PANSS (Depression-C) score at Week 24		Week 24
Primary	Change from baseline in Clinical Global Impressions-Severity (CGI-S) total score at Week 24		Week 24
Primary	Change from baseline in CGI-S total score at Week 24		Week 24
Secondary	Vital signs and weight at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6		Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Secondary	Change from baseline in Clinical Global Impressions-Improvement (CGI-I) score at Week 24		Week 24
Secondary	Adverse events on Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6		Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Secondary	Change from baseline in Global Assessment of Functioning (GAF) score at Week 24		Week 24
Secondary	Laboratory parameters at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6		Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Secondary	Simpson-Angus Scale (SAS) at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6		Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Secondary	Barnes Akathisia Scale (BAS) at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6		Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Secondary	Electrocardiogram		Screening and Month 4

External Links

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