Switch Study of Existing Atypical Antipsychotics to Bifeprunox

NCT00347425

Last updated date
Study Location
Site 148
Birmingham, Alabama, , United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia and Schizoaffective Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Males or females, 18-65 years, meeting DSM-IV TR diagnosis of Schizophrenia or Schizoaffective Disorder for whom a switch is indicated

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


- Acutely psychotic or with a current Axis I primary psychiatric diagnosis other than
schizophrenia or schizoaffective disorder based on DSM-IV TR criteria

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Schizophrenia and Schizoaffective DisorderSwitch Study of Existing Atypical Antipsychotics to Bifeprunox
NCT00347425
  1. Birmingham, Alabama
  2. Little Rock, Arkansas
  3. Anaheim, California
  4. Cerritos, California
  5. Cerritos, California
  6. Culver City, California
  7. Garden Grove, California
  8. La Palma, California
  9. Long Beach, California
  10. Oceanside, California
  11. Paramount, California
  12. Pasadena, California
  13. Sacramento, California
  14. San Diego, California
  15. San Diego, California
  16. Santa Ana, California
  17. Torrance, California
  18. Boca Raton, Florida
  19. Gainesville, Florida
  20. Hialeah, Florida
  21. Jacksonville, Florida
  22. Miami, Florida
  23. North Miami, Florida
  24. North Miami, Florida
  25. Orange City, Florida
  26. Orlando, Florida
  27. Tampa, Florida
  28. Atlanta, Georgia
  29. Augusta, Georgia
  30. Decatur, Georgia
  31. Chicago, Illinois
  32. Indianapolis, Indiana
  33. Lake Charles, Louisiana
  34. Shreveport, Louisiana
  35. Glen Burnie, Maryland
  36. Detroit, Michigan
  37. Minneapolis, Minnesota
  38. St. Charles, Missouri
  39. St. Louis, Missouri
  40. St. Louis, Missouri
  41. Clementon, New Jersey
  42. Kenilworth, New Jersey
  43. Albuquerque, New Mexico
  44. Brooklyn, New York
  45. Cedarhurst, New York
  46. Jamaica, New York
  47. New York, New York
  48. Staten Island, New York
  49. Chagrin Falls, Ohio
  50. Cincinnati, Ohio
  51. Oklahoma City, Oklahoma
  52. Philadelphia, Pennsylvania
  53. Philadelphia, Pennsylvania
  54. Sioux Falls, South Dakota
  55. Memphis, Tennessee
  56. Memphis, Tennessee
  57. Austin, Texas
  58. Conroe, Texas
  59. Houston, Texas
  60. San Antonio, Texas
  61. Richmond, Virginia
  62. Spokane, Washington
  63. Huntington, West Virginia
  64. Buenos Aires,
  65. Buenos Aires,
  66. Cordoba,
  67. La Plata,
  68. Mendoza,
  69. Mendoza,
  70. Mendoza,
  71. Rosario,
  72. Chatham, Ontario
  73. Mississauga, Ontario
  74. Calgary,
  75. Claresholm,
  76. Halifax,
  77. Hull,
  78. Kelowna,
  79. Kingston,
  80. Markham,
  81. Medicine Hat,
  82. Orleans,
  83. Ottawa,
  84. Prince Albert,
  85. Sherbrooke,
  86. Victoria,
  87. Winnipeg,
  88. Bolonska,
  89. Jablonova,
  90. Litomerice,
  91. Na Markvartce,
  92. Olomouc,
  93. Plzen,
  94. Prague,
  95. Praha,
  96. Rejskovo namesti,
  97. Paldksi Mnt,
  98. Tartu,
  99. Voru,
  100. Clermont Ferrand,
  101. Dole,
  102. St. Cyr au Mont d Or,
  103. Balassagyarmat,
  104. Budapest,
  105. Budapest,
  106. Budapest,
  107. Budapest,
  108. Debrecen,
  109. Gyor,
  110. Gyula,
  111. Pecs,
  112. Balvi,
  113. Jelgava,
  114. Liepaja,
  115. Riga,
  116. Sigulda,
  117. Kaunas,
  118. Kaunas,
  119. Klaipeda,
  120. Silute,
  121. Vilnius,
  122. Vilnius,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Switch Study of Existing Atypical Antipsychotics to Bifeprunox
Official Title  ICMJE A Multicenter, Open-Label, Parallel-Group, Randomized, Flexible Dose Study To Evaluate the Safety and Tolerability of Switching From Existing Atypical Antipsychotics to Bifeprunox in Subjects With Schizophrenia or Schizoaffective Disorder
Brief Summary The study will evaluate the safety and tolerability of switching subjects with schizophrenia or schizoaffective disorder from their existing antipsychotic medication to Bifeprunox.
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 and Schizoaffective Disorder
Intervention  ICMJE
  • Drug: Aripiprazole
    Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
  • Drug: Olanzapine
    Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
  • Drug: Risperidone
    Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
  • Drug: Quetiapine
    Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
  • Drug: Ziprasidone
    Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
  • Drug: Aripiprazole
    Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
  • Drug: Olanzapine
    Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
  • Drug: Risperidone
    Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
  • Drug: Quetiapine
    Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
  • Drug: Ziprasidone
    Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
Study Arms  ICMJE
  • A
    Interventions:
    • Drug: Aripiprazole
    • Drug: Olanzapine
    • Drug: Risperidone
    • Drug: Quetiapine
    • Drug: Ziprasidone
  • B
    Interventions:
    • Drug: Aripiprazole
    • Drug: Olanzapine
    • Drug: Risperidone
    • Drug: Quetiapine
    • Drug: Ziprasidone
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
Actual Enrollment  ICMJE
 (submitted: March 20, 2008)
286
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females, 18-65 years, meeting DSM-IV TR diagnosis of Schizophrenia or Schizoaffective Disorder for whom a switch is indicated

Exclusion Criteria:

  • Acutely psychotic or with a current Axis I primary psychiatric diagnosis other than schizophrenia or schizoaffective disorder based on DSM-IV TR criteria
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 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 Argentina,   Canada,   Czech Republic,   Estonia,   France,   Hungary,   Latvia,   Lithuania,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00347425
Other Study ID Numbers  ICMJE S154.3.020
2006-004972-11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Loretta Stallings, Solvay Pharmaceuticals
Study Sponsor  ICMJE Solvay Pharmaceuticals
Collaborators  ICMJE
  • H. Lundbeck A/S
  • Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Director:Global Clinical Director SolvaySolvay Pharmaceuticals
PRS Account Solvay Pharmaceuticals
Verification Date May 2008

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