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

NCT00159770 | Completed Phase 3

• 1 other identifier: A1281079
• Study Type: interventional
• Target: 290
• Locations: 4 countries
• Sites: 43

Brief Summary

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

Conditions

Schizophrenia; Schizoaffective Disorder; Psychotic Disorders

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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

Interventions

ziprasidone versus olanzapine , risperidone or quetiapine DRUG

Panss , CGI-C, UKU-SERS-Pa BEHAVIORAL

Blood tests PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (43)

Pfizer Investigational Site

Aalborg, 9100, Denmark

Location

Pfizer Investigational Site

Arhus C, 8000, Denmark

Location

Pfizer Investigational Site

Augustenborg, 6440, Denmark

Location

Pfizer Investigational Site

Ballerup Municipality, 2750, Denmark

Location

Pfizer Investigational Site

Brovst, 9460, Denmark

Location

Pfizer Investigational Site

Copenhagen, 2100, Denmark

Location

Pfizer Investigational Site

Dianalund, 4293, Denmark

Location

Pfizer Investigational Site

Esbjerg, 6700, Denmark

Location

Pfizer Investigational Site

Esbjerg N, 6715, Denmark

Location

Pfizer Investigational Site

Glostrup Municipality, 2600, Denmark

Location

Pfizer Investigational Site

Haderslev, 6100, Denmark

Location

Pfizer Investigational Site

Holbæk, 4300, Denmark

Location

Pfizer Investigational Site

Kjellerup, 8620, Denmark

Location

Pfizer Investigational Site

Kolding, 6000, Denmark

Location

Pfizer Investigational Site

København S, 2300, Denmark

Location

Pfizer Investigational Site

Lemvig, 7620, Denmark

Location

Pfizer Investigational Site

Odense C, 5000, Denmark

Location

Pfizer Investigational Site

Ringkøbing, 6950, Denmark

Location

Pfizer Investigational Site

Risskov, 8240, Denmark

Location

Pfizer Investigational Site

Vejle, 7100, Denmark

Location

Pfizer Investigational Site

Viborg, 8800, Denmark

Location

Pfizer Investigational Site

Vordingborg, 4760, Denmark

Location

Pfizer Investigational Site

Forssa, 30101, Finland

Location

Pfizer Investigational Site

Helsinki, 00099, Finland

Location

Pfizer Investigational Site

Jarvenpaa, 04400, Finland

Location

Pfizer Investigational Site

Kiviranta, 95410, Finland

Location

Pfizer Investigational Site

Mikkeli, 50520, Finland

Location

Pfizer Investigational Site

Turku, 20700, Finland

Location

Pfizer Investigational Site

Tuusula, 04301, Finland

Location

Pfizer Investigational Site

Reykjavik, 101, Iceland

Location

Pfizer Investigational Site

Basel, Canton of Basel-City, CH-4025, Switzerland

Location

Pfizer Investigational Site

Bern, Canton of Bern, CH-3000, Switzerland

Location

Pfizer Investigational Site

Sankt Gallen, Canton of St. Gallen, 9000, Switzerland

Location

Pfizer Investigational Site

Lausanne, Canton of Vaud, 1003, Switzerland

Location

Pfizer Investigational Site

Prangins, Canton of Vaud, 1197, Switzerland

Location

Pfizer Investigational Site

Zurich, Canton of Zurich, 8029, Switzerland

Location

Pfizer Investigational Site

Bulle, CH - 1630, Switzerland

Location

Pfizer Investigational Site

Chêne-Bourg, 1225, Switzerland

Location

Pfizer Investigational Site

Delémont, CH-2800, Switzerland

Location

Pfizer Investigational Site

Oetwil, CH-8618, Switzerland

Location

Pfizer Investigational Site

Riehen, 4125, Switzerland

Location

Pfizer Investigational Site

Saint Urban, 4915, Switzerland

Location

Pfizer Investigational Site

Solothurn, CH-4503, Switzerland

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Risperidone; Quetiapine Fumarate; Hematologic Tests

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: November 1, 2001
• Study Completion: September 1, 2004
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

IC (1); FI (7); DK (22); CH (13)