Effect And Safety Of Ziprasidone Compared To Other Atypical Antipsychotic Drug In Schizophrenic Patients

Overview

Evaluation of the antipsychotic efficacy and safety of ziprasidone versus olanzapine, risperidone or quetiapine in patients with schizophrenia, schizoaffective and schizophreniform disorders under naturalistic conditions of clinical practice

Full Title of Study: “Tolerability, Safety, And Efficacy Of Ziprasidone (80 – 160 Mg/D) Versus Olanzapine (10 – 20 Mg/D), Risperidone (4 – 8 Mg/D) Or Quetiapine (300 – 750 Mg/D) In Pretreated Patients With Schizophrenia, Schizoaffective Disorder Or Schizophreniform Disorders – A 12-Week Open-Label, Multicenter Clinical Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Interventions

  • Drug: ziprasidone versus olanzapine , risperidone or quetiapine
  • Behavioral: Panss , CGI-C, UKU-SERS-Pa
  • Procedure: Blood tests

Clinical Trial Outcome Measures

Primary Measures

  • PANSS (The Positive And Negative Syndrome Scale) in a 12 week period

Secondary Measures

  • CGI-C score (Clinical Global Impression of Change), UKU-SERS-Pa (Patient self rating version). Safety and tolerability: ECG, serum cholesterol, triglycerides, prolactin, glucose and body weight

Participating in This Clinical Trial

Inclusion Criteria

  • Inpatients or outpatients with schizophrenia, schizoaffective and schizophreniform disorders (DSM-IV). – Patients without adequate current treatment (i.e. intolerance to their current treatment or lack of efficacy of current treatment) based on clinical judgement of the investigator Exclusion Criteria:

  • A history of intolerance to ziprasidone, olanzapine, risperidone or quetiapine or any of its ingredients

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer’s Upjohn has merged with Mylan to form Viatris Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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