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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00649064

Enrollment

Registered

2008-04-01

Start date

2003-12-31

Completion date

2004-09-30

Last updated

2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective Disorder, Schizophrenia

Brief 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.

Interventions

DRUGZiprasidone

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in Brief Psychiatric Rating Scale (BPRS) total score	Week 6

Secondary

Measure	Time frame
Change from baseline in weight	Baseline and Week 6
Change from baseline in prolactin and lipid levels	Baseline and Week 6
Change from baseline in electrocardiogram	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	Baseline and Weeks 1, 2, and 6
Adverse events	Weeks 1, 2, and 6
Clinical Global Impressions-Improvement (CGI-I) scale scores	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)	Baseline and Week 6
Change from baseline in vital signs	Baseline and Weeks 1, 2, and 6
Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) scores	Baseline and Week 6
Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores	Baseline and Weeks 1, 2, and 6

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026