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

February 18, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

290

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Denmark
- - Aalborg, Denmark, 9100
    - Pfizer Investigational Site
  - Arhus C, Denmark, 8000
    - Pfizer Investigational Site
  - Augustenborg, Denmark, 6440
    - Pfizer Investigational Site
  - Ballerup, Denmark, 2750
    - Pfizer Investigational Site
  - Brovst, Denmark, 9460
    - Pfizer Investigational Site
  - Dianalund, Denmark, 4293
    - Pfizer Investigational Site
  - Esbjerg, Denmark, 6700
    - Pfizer Investigational Site
  - Esbjerg N, Denmark, 6715
    - Pfizer Investigational Site
  - Glostrup, Denmark, 2600
    - Pfizer Investigational Site
  - Haderslev, Denmark, 6100
    - Pfizer Investigational Site
  - Holbaek, Denmark, 4300
    - Pfizer Investigational Site
  - Kjellerup, Denmark, 8620
    - Pfizer Investigational Site
  - Kobenhavn, Denmark, 2100
    - Pfizer Investigational Site
  - Kobenhavn S, Denmark, 2300
    - Pfizer Investigational Site
  - Kolding, Denmark, 6000
    - Pfizer Investigational Site
  - Lemvig, Denmark, 7620
    - Pfizer Investigational Site
  - Odense C, Denmark, 5000
    - Pfizer Investigational Site
  - Ringkobing, Denmark, 6950
    - Pfizer Investigational Site
  - Risskov, Denmark, 8240
    - Pfizer Investigational Site
  - Vejle, Denmark, 7100
    - Pfizer Investigational Site
  - Viborg, Denmark, 8800
    - Pfizer Investigational Site
  - Vordingborg, Denmark, 4760
    - Pfizer Investigational Site
Finland
- - Forssa, Finland, 30101
    - Pfizer Investigational Site
  - Helsinki, Finland, 00099
    - Pfizer Investigational Site
  - Jarvenpaa, Finland, 04400
    - Pfizer Investigational Site
  - Kiviranta, Finland, 95410
    - Pfizer Investigational Site
  - Mikkeli, Finland, 50520
    - Pfizer Investigational Site
  - Turku, Finland, 20700
    - Pfizer Investigational Site
  - Tuusula, Finland, 04301
    - Pfizer Investigational Site
Iceland
- - Reykjavik, Iceland, 101
    - Pfizer Investigational Site
Switzerland
- - Bulle, Switzerland, CH - 1630
    - Pfizer Investigational Site
  - Chene-bourg, Switzerland, 1225
    - Pfizer Investigational Site
  - Delemont, Switzerland, CH-2800
    - Pfizer Investigational Site
  - Oetwil, Switzerland, CH-8618
    - Pfizer Investigational Site
  - Riehen, Switzerland, 4125
    - Pfizer Investigational Site
  - Saint Urban, Switzerland, 4915
    - Pfizer Investigational Site
  - Solothurn, Switzerland, CH-4503
    - Pfizer Investigational Site
- BE
  - Bern 60, BE, Switzerland, CH-3000
    - Pfizer Investigational Site
- BS
  - Basel, BS, Switzerland, CH-4025
    - Pfizer Investigational Site
- SG
  - St. Gallen, SG, Switzerland, 9000
    - Pfizer Investigational Site
- VD
  - Lausanne, VD, Switzerland, 1003
    - Pfizer Investigational Site
  - Prangins, VD, Switzerland, 1197
    - Pfizer Investigational Site
- ZH
  - Zurich, ZH, Switzerland, 8029
    - Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Study Completion

September 1, 2004

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

A1281079

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.