- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00159770
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
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
-
-
-
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
-
-
-
-
-
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
-
-
-
-
-
Reykjavik, Iceland, 101
- Pfizer Investigational Site
-
-
-
-
-
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
No
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.
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
- Pathologic Processes
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Disease
- Psychotic Disorders
- Mental Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Olanzapine
- Quetiapine Fumarate
- Risperidone
- Ziprasidone
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.
Clinical Trials on Psychotic Disorders
-
Medical College of WisconsinCompletedSchizophrenia | Affective Disorders | Psychotic Disorder | Psychotic Mood Disorder
-
Søren Dinesen ØstergaardCompletedAffective Disorders, PsychoticDenmark
-
Instituto de Investigación Hospital Universitario...CompletedSchizophrenia and Disorders With Psychotic Feature | Psychotic EpisodeSpain
-
Instituto de Investigación Hospital Universitario...Carlos III Health Institute; European Regional Development FundCompletedSchizophrenia and Disorders With Psychotic Features | Psychotic EpisodeSpain
-
University of MinnesotaUniversity of California, San FranciscoCompletedPsychotic Disorders | Schizophrenia | Schizoaffective Disorder | Cognitive Impairment | Psychosis | Treatment | Psychotic Depression | Psychotic Episode | Active Control | Psychotic Mood DisordersUnited States
-
Centre hospitalier de Ville-Evrard, FranceRecruiting
-
VA Office of Research and DevelopmentNot yet recruitingMI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMIHomelessness | Schizophrenia Spectrum Disorders | Psychotic Mood Disorders | Psychotic Affective Disorders | Ill-Housed PersonsUnited States
-
University of California, San DiegoActive, not recruitingSchizophrenia | Schizoaffective Disorder | Mood Disorder, PsychoticUnited States
-
University Hospital, CaenRecruiting
-
Boston Medical CenterNational Institute of Mental Health (NIMH); Beth Israel Deaconess Medical CenterCompletedPsychotic Disorders | Psychosis | Psychotic EpisodeUnited States
Clinical Trials on Blood tests
-
University of Colorado, DenverTerminatedVenous ThromboembolismUnited States
-
The Netherlands Cancer InstituteBayerCompletedBone Metastases | Prostate Cancer MetastaticNetherlands
-
Centre Hospitalier Universitaire, AmiensCompletedCardiovascular AbnormalitiesFrance
-
Calimmune, Inc.Active, not recruitingHIV-1 Infection | Receipt of Cal-1 Modified Hematopoietic Cellular ProductsUnited States
-
HaEmek Medical Center, IsraelCompleted
-
University of SussexUniversity of OxfordRecruiting
-
Cwm Taf University Health Board (NHS)Cardiff University; Imperial College London; University of OxfordCompletedDiabetes Mellitus, Type 1 | SARS-CoV2 InfectionUnited Kingdom
-
Aga Khan UniversityCompletedOrthopedic Disorder
-
Carmel Medical CenterCompleted
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); Alaunos Therapeutics; National Center for Research...RecruitingRetroviridae Infections | CancerUnited States