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Trial record 1 of 1 for:    NCT00159770
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Effect And Safety Of Ziprasidone Compared To Other Atypical Antipsychotic Drug In Schizophrenic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00159770
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 1, 2007
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 12, 2005
Last Update Posted Date January 1, 2007
Study Start Date  ICMJE November 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2005)
PANSS (The Positive And Negative Syndrome Scale) in a 12 week period
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2005)
Improvement on PANSS (The Positive And Negative Syndrome Scale) in a 12 week period
Change History Complete list of historical versions of study NCT00159770 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2005)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2005)
Improvement on the CGI-C score (Clinical Global Impression of Change) in a 12 week period. Improvement on UKU-SERS-Pa (Patient self rating version)in a 12 week period. Safety and tolerability including ECG, serum cholesterol, serum triglycerides, serum p
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect And Safety Of Ziprasidone Compared To Other Atypical Antipsychotic Drug In Schizophrenic Patients
Official Title  ICMJE 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.
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Schizoaffective Disorder
  • Psychotic Disorders
Intervention  ICMJE
  • Drug: ziprasidone versus olanzapine , risperidone or quetiapine
  • Behavioral: Panss , CGI-C, UKU-SERS-Pa
  • Procedure: Blood tests
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 11, 2005)
290
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE September 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Finland,   Iceland,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00159770
Other Study ID Numbers  ICMJE A1281079
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP