A Study Comparing the Safety and Efficacy of Ziprasidone and Risperidone for the Treatment of Chronic Schizophrenia

Back to Search
Print
Bookmark Trial

NCT00645515

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bilbao, Vizcaya, 48010, Spain
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

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

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of schizophrenia

- CGI-S score of 4 or less at baseline

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


- Concurrent antipsychotic treatment


- Treatment with antidepressants or mood stabilizers within 2 weeks of randomization


- Acute exacerbation of schizophrenia within 3 months of baseline

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

SchizophreniaStudy Evaluating the Effects of Multiple Doses of NSA-789 in Subjects With Schizophrenia or Schizoaffective Disorder NCT00892021
  1. Rockville, Maryland
ALL GENDERS
18 Years+
years
MULTIPLE SITES
SchizophreniaLarge Simple Trial (LST) Of Cardiovascular Safety Of Ziprasidone And Olanzapine- (Zodiac) NCT00418171
  1. San Bernardino, California
  2. Aiea, Hawaii
  3. Schaumburg, Illinois
  4. Grants Pass, Oregon
  5. Whitehall, West Virginia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
SchizophreniaAn Outpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Adjunctive Treatment Of Sub-Optimally Controlled Symptoms of Schizophrenia NCT01939548
  1. Birmingham, Alabama
  2. Little Rock, Arkansas
  3. Cerritos, California
  4. Culver City, California
  5. Escondido, California
  6. Garden Grove, California
  7. Oakland, California
  8. Oceanside, California
  9. Orange, California
  10. Riverside, California
  11. San Diego, California
  12. San Diego, California
  13. Torrance, California
  14. Hartford, Connecticut
  15. Hartford, Connecticut
  16. New Haven, Connecticut
  17. Washington, District of Columbia
  18. Bradenton, Florida
  19. Brandenton, Florida
  20. Lauderhill, Florida
  21. Sanford, Florida
  22. Atlanta, Georgia
  23. Hoffman Estates, Illinois
  24. Hoffman Estates, Illinois
  25. Schaumburg, Illinois
  26. Lake Charles, Louisiana
  27. Shreveport, Louisiana
  28. Rockville, Maryland
  29. O'Fallon, Missouri
  30. St. Louis, Missouri
  31. Las Vegas, Nevada
  32. Jamaica, New York
  33. New York, New York
  34. Ward's Island, New York
  35. Dayton, Ohio
  36. Oklahoma City, Oklahoma
  37. Memphis, Tennessee
  38. Austin, Texas
  39. Austin, Texas
  40. Dallas, Texas
  41. Dallas, Texas
  42. DeSoto, Texas
  43. Salt Lake City, Utah
  44. Salt Lake City, Utah
ALL GENDERS
18 Years+
years
MULTIPLE SITES
SchizophreniaAn Inpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Treatment Of Acute Exacerbation Of Schizophrenia NCT01175135
  1. Little Rock, Arkansas
  2. Anaheim, California
  3. Escondido, California
  4. Escondido, California
  5. Garden Grove, California
  6. Long Beach, California
  7. Long Beach, California
  8. Orange, California
  9. Paramount, California
  10. Paramount, California
  11. San Diego, California
  12. Santa Ana, California
  13. Torrance, California
  14. Torrance, California
  15. Washington, District of Columbia
  16. Bradenton, Florida
  17. Maitland, Florida
  18. Orlando, Florida
  19. Atlanta, Georgia
  20. Hoffman Estates, Illinois
  21. Hoffman Estates, Illinois
  22. Hoffman Estates, Illinois
  23. Lake Charles, Louisiana
  24. Lake Charles, Louisiana
  25. Rockville, Maryland
  26. Saint Louis, Missouri
  27. Willingboro, New Jersey
  28. Willingboro, New Jersey
  29. Hollis, New York
  30. Philadelphia, Pennsylvania
  31. Austin, Texas
  32. Austin, Texas
  33. Austin, Texas
  34. DeSoto, Texas
  35. Houston, Texas
  36. Houston, Texas
  37. Kirkland, Washington
  38. Kirkland, Washington
  39. Mannheim,
  40. Dnipropetrovsk,
  41. Dnipropetrovsk,
  42. Kyiv,
  43. Kyiv,
  44. Lugansk,
  45. Poltava,
  46. Stepanivka, Kherson,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Comparing the Safety and Efficacy of Ziprasidone and Risperidone for the Treatment of Chronic Schizophrenia
Official Title  ICMJE Ziprasidone Versus Risperidone In The Treatment Of Chronic Schizophrenia: A Six Months, Double Blind Randomized, Parallel Group Study
Brief Summary The purpose of this study is to compare the safety of ziprasidone and risperidone for the treatment of chronic schizophrenia. The primary purpose is to differentiate the effects of ziprasidone and risperidone on extrapyramidal side effects and the secondary purpose is to compare their tolerability and efficacy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Ziprasidone
    Initial dose of 40 mg capsules twice daily on Days 1-3; dose could be flexibly changed within the range of 40 to 80 mg twice daily for the remainder of the study; treatment duration was 24 weeks.
    Other Name: Geodon, Zeldox
  • Drug: Risperidone
    Initial dose of 10 mg once daily on Days 1-3; dose could be flexibly changed within the range of 3 to 9 mg twice daily for the remainder of the study; treatment duration was 24 weeks.
Study Arms  ICMJE
  • Experimental: Arm A
    Intervention: Drug: Ziprasidone
  • Active Comparator: Arm B
    Intervention: Drug: Risperidone
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 Terminated
Estimated Enrollment  ICMJE
 (submitted: March 20, 2008)		240
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of schizophrenia
  • CGI-S score of 4 or less at baseline

Exclusion Criteria:

  • Concurrent antipsychotic treatment
  • Treatment with antidepressants or mood stabilizers within 2 weeks of randomization
  • Acute exacerbation of schizophrenia within 3 months of baseline
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (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 Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00645515
Other Study ID Numbers  ICMJE A1281065
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2008

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