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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizoaffective Disorder Schizophrenia

Interventions

ZiprasidoneDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (3)

Pfizer Investigational Site

Changhua, Taiwan

Pfizer Investigational Site

Tainan, Taiwan

Pfizer Investigational Site

Taipei, Taiwan

Outcomes

Primary Outcomes

Change from baseline in Brief Psychiatric Rating Scale (BPRS) total score

Time frame: Week 6

Secondary Outcomes

Adverse events

Time frame: Weeks 1, 2, and 6

Change from baseline in weight

Time frame: Baseline and Week 6

Change from baseline in prolactin and lipid levels

Time frame: Baseline and Week 6

Change from baseline in electrocardiogram

Time frame: Baseline and Week 6

Change from baseline in Positive and Negative Symptom Scale (PANSS), including PANSS total scores and PANSS positive, PANSS negative, and PANSS general subscale scores

Time frame: Baseline and Weeks 1, 2, and 6

Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores

Time frame: Baseline and Weeks 1, 2, and 6

Clinical Global Impressions-Improvement (CGI-I) scale scores

Time frame: Baseline (using historical data) and Weeks 1, 2, and 6

Change from baseline in movement disorder rating scales, including Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movement Scale (AIMS)

Time frame: Baseline and Week 6

Change from baseline in vital signs

Time frame: Baseline and Weeks 1, 2, and 6

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.