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NCT00159770 Clinical Trial

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

Schizophrenia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00159770
Other study ID # A1281079
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 2001
Est. completion date September 2004

Study information
Verified date February 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 290
Est. completion date September 2004
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• ziprasidone versus olanzapine , risperidone or quetiapine

Behavioral:
• Panss , CGI-C, UKU-SERS-Pa

Procedure:
• Blood tests

Locations
Country Name City State
Denmark Pfizer Investigational Site Aalborg
Denmark Pfizer Investigational Site Arhus C
Denmark Pfizer Investigational Site Augustenborg
Denmark Pfizer Investigational Site Ballerup
Denmark Pfizer Investigational Site Brovst
Denmark Pfizer Investigational Site Dianalund
Denmark Pfizer Investigational Site Esbjerg
Denmark Pfizer Investigational Site Esbjerg N
Denmark Pfizer Investigational Site Glostrup
Denmark Pfizer Investigational Site Haderslev
Denmark Pfizer Investigational Site Holbaek
Denmark Pfizer Investigational Site Kjellerup
Denmark Pfizer Investigational Site Kobenhavn
Denmark Pfizer Investigational Site Kobenhavn S
Denmark Pfizer Investigational Site Kolding
Denmark Pfizer Investigational Site Lemvig
Denmark Pfizer Investigational Site Odense C
Denmark Pfizer Investigational Site Ringkobing
Denmark Pfizer Investigational Site Risskov
Denmark Pfizer Investigational Site Vejle
Denmark Pfizer Investigational Site Viborg
Denmark Pfizer Investigational Site Vordingborg
Finland Pfizer Investigational Site Forssa
Finland Pfizer Investigational Site Helsinki
Finland Pfizer Investigational Site Jarvenpaa
Finland Pfizer Investigational Site Kiviranta
Finland Pfizer Investigational Site Mikkeli
Finland Pfizer Investigational Site Turku
Finland Pfizer Investigational Site Tuusula
Iceland Pfizer Investigational Site Reykjavik
Switzerland Pfizer Investigational Site Basel BS
Switzerland Pfizer Investigational Site Bern 60 BE
Switzerland Pfizer Investigational Site Bulle
Switzerland Pfizer Investigational Site Chene-bourg
Switzerland Pfizer Investigational Site Delemont
Switzerland Pfizer Investigational Site Lausanne VD
Switzerland Pfizer Investigational Site Oetwil
Switzerland Pfizer Investigational Site Prangins VD
Switzerland Pfizer Investigational Site Riehen
Switzerland Pfizer Investigational Site Saint Urban
Switzerland Pfizer Investigational Site Solothurn
Switzerland Pfizer Investigational Site St. Gallen SG
Switzerland Pfizer Investigational Site Zurich ZH

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Denmark,  Finland,  Iceland,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary PANSS (The Positive And Negative Syndrome Scale) in a 12 week period
Secondary 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
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