Study Comparing the Affect of Bifeprunox Vs Olanzapine on Weight During the Treatment of Outpatients With Schizophrenia.

NCT00380224

Last updated date
Study Location
Little Rock, Arkansas, 72201, United States
Contact
1-800-718-1021

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
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Current treatment of at least 3 months with olanzapine.

- Primary diagnosis of schizophrenia.

- Total Positive and Negative Symptoms Scale (PANSS) score <=70 at screening and baseline.

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


- Psychiatric diagnosis other than schizophrenia, as assessed by the modified Mini
International Neuropsychiatric Interview (MINI), and considered by the investigator to
be the primary psychiatric diagnosis.


- History or presence of clinically significant cardiovascular, endocrine, hepatic,
renal or other medical disease that might be detrimental to the subject or confound
the study.


- History of any suicide attempt within 3 years of day -1 or significant immediate risk
of violence or suicidality.

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]

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.

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 Study Comparing the Affect of Bifeprunox Vs Olanzapine on Weight During the Treatment of Outpatients With Schizophrenia.
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Parallel-Group Fixed-Dose Study of the Effect on Weight of Befeprunox Versus Olanzapine in the Treatment of Outpatients With Schizophrenia.
Brief Summary This study will compare bifeprunox to a currently marketed medication, Zyprexa (olanzapine), with respect to the affect on weight during the treatment of outpatients with schizophrenia. The study will compare the effect of these medications on several variables, including body weight and triglyceride levels.
Detailed Description This is a multicenter, randomized, double-blind, parallel-group study of bifeprunox in the treatment of outpatients with schizophrenia, with olanzapine as the active comparator. Subjects must be stable for 3 months or more of treatment with olanzapine at baseline. There will be 2 treatment arms in this study, approximately 60 subjects per arm. After randomization and blinding, each subject will either remain on olanzapine or switch to bifeprunox. Assessments, including body weight and waist measurements, will be made at each study visit.Subjects will participate in the study for approximately 11 weeks. After a screening period of 6 to 14 days, eligible subjects will be treated for 8 weeks. Subjects who do not enter the long-term extension will return for a follow-up visit 7 days after discontinuing the use of test article. Subjects who do enter the long-term extension will have a 7-day taper/titration period after the 8 weeks of double-blind treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE Drug: bifeprunox, olanzapine
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
Estimated Enrollment  ICMJE
 (submitted: September 21, 2006)
120
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Current treatment of at least 3 months with olanzapine.
  • Primary diagnosis of schizophrenia.
  • Total Positive and Negative Symptoms Scale (PANSS) score <=70 at screening and baseline.

Exclusion criteria:

  • Psychiatric diagnosis other than schizophrenia, as assessed by the modified Mini International Neuropsychiatric Interview (MINI), and considered by the investigator to be the primary psychiatric diagnosis.
  • History or presence of clinically significant cardiovascular, endocrine, hepatic, renal or other medical disease that might be detrimental to the subject or confound the study.
  • History of any suicide attempt within 3 years of day -1 or significant immediate risk of violence or suicidality.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00380224
Other Study ID Numbers  ICMJE 3168A1-311
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 Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

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