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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00159770
First received: September 8, 2005
Last updated: December 28, 2006
Last verified: December 2006
  Purpose

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
Schizophrenia
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159770

  Show 43 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

ClinicalTrials.gov 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
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Risperidone
Quetiapine
Olanzapine
Ziprasidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 23, 2014