Clinical trial NCT00159770: Effect And Safety Of Ziprasidone Compared To Other Atypical Antipsychotic Drug In Schizophrenic Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Schizoaffective Disorder
Psychotic Disorders
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: PANSS (The Positive And Negative Syndrome Scale) in a 12 week period
Secondary outcomes:
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
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Pfizer Investigational Site
city: Arhus C
country: Denmark
facility: Pfizer Investigational Site
city: Augustenborg
country: Denmark
facility: Pfizer Investigational Site
city: Ballerup
country: Denmark
facility: Pfizer Investigational Site
city: Brovst
country: Denmark
facility: Pfizer Investigational Site
city: Dianalund
country: Denmark
facility: Pfizer Investigational Site
city: Esbjerg N
country: Denmark
facility: Pfizer Investigational Site
city: Esbjerg
country: Denmark
facility: Pfizer Investigational Site
city: Glostrup
country: Denmark
facility: Pfizer Investigational Site
city: Haderslev
country: Denmark
facility: Pfizer Investigational Site
city: Holbaek
country: Denmark
facility: Pfizer Investigational Site
city: Kjellerup
country: Denmark
facility: Pfizer Investigational Site
city: Kobenhavn S
country: Denmark
facility: Pfizer Investigational Site
city: Kobenhavn
country: Denmark
facility: Pfizer Investigational Site
city: Kolding
country: Denmark
facility: Pfizer Investigational Site
city: Lemvig
country: Denmark
facility: Pfizer Investigational Site
city: Odense C
country: Denmark
facility: Pfizer Investigational Site
city: Ringkobing
country: Denmark
facility: Pfizer Investigational Site
city: Risskov
country: Denmark
facility: Pfizer Investigational Site
city: Vejle
country: Denmark
facility: Pfizer Investigational Site
city: Viborg
country: Denmark
facility: Pfizer Investigational Site
city: Vordingborg
country: Denmark
facility: Pfizer Investigational Site
city: Forssa
country: Finland
facility: Pfizer Investigational Site
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Jarvenpaa
country: Finland
facility: Pfizer Investigational Site
city: Kiviranta
country: Finland
facility: Pfizer Investigational Site
city: Mikkeli
country: Finland
facility: Pfizer Investigational Site
city: Turku
country: Finland
facility: Pfizer Investigational Site
city: Tuusula
country: Finland
facility: Pfizer Investigational Site
city: Reykjavik
country: Iceland
facility: Pfizer Investigational Site
city: Bern 60
country: Switzerland
facility: Pfizer Investigational Site
state: BE
city: Basel
country: Switzerland
facility: Pfizer Investigational Site
state: BS
city: St. Gallen
country: Switzerland
facility: Pfizer Investigational Site
state: SG
city: Lausanne
country: Switzerland
facility: Pfizer Investigational Site
state: VD
city: Prangins
country: Switzerland
facility: Pfizer Investigational Site
state: VD
city: Zurich
country: Switzerland
facility: Pfizer Investigational Site
state: ZH
city: Bulle
country: Switzerland
facility: Pfizer Investigational Site
city: Chene-bourg
country: Switzerland
facility: Pfizer Investigational Site
city: Delemont
country: Switzerland
facility: Pfizer Investigational Site
city: Oetwil
country: Switzerland
facility: Pfizer Investigational Site
city: Riehen
country: Switzerland
facility: Pfizer Investigational Site
city: Saint Urban
country: Switzerland
facility: Pfizer Investigational Site
city: Solothurn
country: Switzerland
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: