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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 8, 2005
Last updated: December 28, 2006
Last verified: December 2006
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

Condition Intervention Phase
Schizoaffective Disorder
Psychotic Disorders
Drug: ziprasidone versus olanzapine , risperidone or quetiapine
Behavioral: Panss , CGI-C, UKU-SERS-Pa
Procedure: Blood tests
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • PANSS (The Positive And Negative Syndrome Scale) in a 12 week period

Secondary Outcome 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

Estimated Enrollment: 290
Study Start Date: November 2001
Estimated Study Completion Date: September 2004

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00159770

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Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information Identifier: NCT00159770     History of Changes
Other Study ID Numbers: A1281079 
Study First Received: September 8, 2005
Last Updated: December 28, 2006
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin Antagonists
Dopamine Antagonists
Dopamine Agents processed this record on October 25, 2016