A Study of the Effects of Ziprasidone for the Treatment of Schizophrenia or Schizoaffective Disorder in Patients Who Were Switched From Other Antipsychotic Drugs

Schizophrenia Clinical Trial

Official title:

A Multi-Center Study To Examine The Clinical Effects Of Cross Titration Of Antipsychotics With Ziprasidone In Subjects With Schizophrenia Or Schizoaffective Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00649064
• Other study ID #: A1281120
• Status: Completed
• Phase: Phase 4
• Start date: December 2003
• Est. completion date: September 2004

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 see if differences exist in outcome in patients with schizophrenia or schizoaffective disorder who were switched from other antipsychotics to ziprasidone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of schizophrenia or schizoaffective disorder

• Outpatients for at least 3 months on treatment with sulpiride, olanzapine, quetiapine, or risperidone and at least a partial beneficial response to typical antipsychotic treatment including for the current episode

• Partial improvement in symptoms that justified a switch to ziprasidone

Exclusion Criteria:

• Diagnosis of major depression or occurrence of moderate depressive symptoms

• Resistance to conventional antipsychotic drugs

• Treatment with other drugs such as antiseizure medications, antipsychotics, antidepressants, or mood stabilizing agents that might interfere with the assessement of the efficacy of ziprasidone

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Ziprasidone
Ziprasidone 40 mg capsules twice daily for the first 7 days followed by flexible dosing between 40 and 80 mg twice daily for the remaining 5 weeks.

Locations

Country	Name	City	State
Taiwan	Pfizer Investigational Site	Changhua
Taiwan	Pfizer Investigational Site	Tainan
Taiwan	Pfizer Investigational Site	Taipei

Sponsors (1)

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

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Brief Psychiatric Rating Scale (BPRS) total score		Week 6
Secondary	Adverse events		Weeks 1, 2, and 6
Secondary	Change from baseline in weight		Baseline and Week 6
Secondary	Change from baseline in prolactin and lipid levels		Baseline and Week 6
Secondary	Change from baseline in electrocardiogram		Baseline and Week 6
Secondary	Change from baseline in Positive and Negative Symptom Scale (PANSS), including PANSS total scores and PANSS positive, PANSS negative, and PANSS general subscale scores		Baseline and Weeks 1, 2, and 6
Secondary	Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores		Baseline and Weeks 1, 2, and 6
Secondary	Clinical Global Impressions-Improvement (CGI-I) scale scores		Baseline (using historical data) and Weeks 1, 2, and 6
Secondary	Change from baseline in movement disorder rating scales, including Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movement Scale (AIMS)		Baseline and Week 6
Secondary	Change from baseline in vital signs		Baseline and Weeks 1, 2, and 6
Secondary	Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) scores		Baseline and Week 6

External Links

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