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Completed

NCT Number: NCT00649064

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

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.

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Key information

Conditions

Schizoaffective Disorder Mental Disorders Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Changhua, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ziprasidone

Drug

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.

Other names: Geodon, Zeldox

Primary outcomes

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

    Time frame: Week 6

Secondary outcomes

  1. Adverse events

    Time frame: Weeks 1, 2, and 6

  2. Change from baseline in weight

    Time frame: Baseline and Week 6

  3. Change from baseline in prolactin and lipid levels

    Time frame: Baseline and Week 6

  4. Change from baseline in electrocardiogram

    Time frame: Baseline and Week 6

  5. 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

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

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

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

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

  8. 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

  9. Change from baseline in vital signs

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

  10. Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) scores

    Time frame: Baseline and Week 6

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2004
First posted
Apr 1, 2008
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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