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

NCT00159770

Last updated date
Study Location
Pfizer Investigational Site
Aalborg, , 9100, Denmark
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia, Schizoaffective Disorder, Psychotic Disorders
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Schizophrenia, Schizoaffective Disorder, Psychotic DisordersEffect And Safety Of Ziprasidone Compared To Other Atypical Antipsychotic Drug In Schizophrenic Patients
NCT00159770
  1. Aalborg,
  2. Arhus C,
  3. Augustenborg,
  4. Ballerup,
  5. Brovst,
  6. Dianalund,
  7. Esbjerg N,
  8. Esbjerg,
  9. Glostrup,
  10. Haderslev,
  11. Holbaek,
  12. Kjellerup,
  13. Kobenhavn S,
  14. Kobenhavn,
  15. Kolding,
  16. Lemvig,
  17. Odense C,
  18. Ringkobing,
  19. Risskov,
  20. Vejle,
  21. Viborg,
  22. Vordingborg,
  23. Forssa,
  24. Helsinki,
  25. Jarvenpaa,
  26. Kiviranta,
  27. Mikkeli,
  28. Turku,
  29. Tuusula,
  30. Reykjavik,
  31. Bern 60, BE
  32. Basel, BS
  33. St. Gallen, SG
  34. Lausanne, VD
  35. Prangins, VD
  36. Zurich, ZH
  37. Bulle,
  38. Chene-bourg,
  39. Delemont,
  40. Oetwil,
  41. Riehen,
  42. Solothurn,
  43. St. Urban,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 CenterPfizer
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