Adjunctive Ziprasidone in the Treatment of Bipolar I Depression

NCT00483548

Last updated date
Study Location
Pfizer Investigational Site
Chandler, Arizona, 85226, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bipolar Disorder, Bipolar Depression
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

- Adults meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for Bipolar I disorder, most recent episode depressed, with or without rapid cycling and without psychotic features. Subjects receive therapeutic dose of lithium, valproate or lamotrigine for at least 4 weeks prior to randomization.

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


- Patients with ultra-fast rapid cycling (8 or more mood episodes per year)


- Significant heart disease including abnormalities in the heart's rhythm (QT
prolongation)


- Psychotic symptoms (hallucinations and/or delusions).

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Bipolar Disorder, Bipolar DepressionAdjunctive Ziprasidone in the Treatment of Bipolar I Depression
NCT00483548
  1. Chandler, Arizona
  2. Litchfield Park, Arizona
  3. Little Rock, Arkansas
  4. Little Rock, Arkansas
  5. Springdale, Arkansas
  6. Costa Mesa, California
  7. Oceanside, California
  8. San Diego, California
  9. Torrance, California
  10. Boca Raton, Florida
  11. Boca Raton, Florida
  12. Jacksonville, Florida
  13. Orlando, Florida
  14. Sanford, Florida
  15. St. Petersburg, Florida
  16. West Palm Beach, Florida
  17. Chicago, Illinois
  18. Skokie, Illinois
  19. Greenwood, Indiana
  20. Indianapolis, Indiana
  21. Topeka, Kansas
  22. Wichita, Kansas
  23. Lake Charles, Louisiana
  24. Rockville, Maryland
  25. Boston, Massachusetts
  26. Watertown, Massachusetts
  27. Clinton Township, Michigan
  28. St. Charles, Missouri
  29. St. Louis, Missouri
  30. Lincoln, Nebraska
  31. Nashua, New Hampshire
  32. Cherry Hill, New Jersey
  33. Clementon, New Jersey
  34. Brooklyn, New York
  35. Glen Oaks, New York
  36. New York, New York
  37. Olean, New York
  38. Rochester, New York
  39. Staten Island, New York
  40. Chapel Hill, North Carolina
  41. Cincinnati, Ohio
  42. Cincinnati, Ohio
  43. Columbus, Ohio
  44. Dayton, Ohio
  45. Oklahoma City, Oklahoma
  46. Oklahoma City, Oklahoma
  47. Portland, Oregon
  48. Philadelphia, Pennsylvania
  49. Philadelphia, Pennsylvania
  50. Memphis, Tennessee
  51. Austin, Texas
  52. Austin, Texas
  53. Houston, Texas
  54. Houston, Texas
  55. Lake Jackson, Texas
  56. Charlottesville, Virginia
  57. Kirkland, Washington
  58. Richland, Washington
  59. Seattle, Washington
  60. Brown Deer, Wisconsin
  61. Westmead, New South Wales
  62. Everton Park, Queensland
  63. Spring Hill, Queensland
  64. Richmond, Victoria
  65. Ellisbridge, Ahmedabad
  66. Ahmedabad, Gujarat
  67. Aurangabad, Maharashtra
  68. Pune, Maharashtra
  69. Pune, Maharashtra
  70. Delhi, New Delhi
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Adjunctive Ziprasidone in the Treatment of Bipolar I Depression
Official Title  ICMJE A Six-Week, Double-Blind, Multicenter, Placebo Controlled Study Evaluating The Efficacy And Safety Of Flexible Doses Of Oral Ziprasidone As Add-On, Adjunctive Therapy With Lithium, Valproate Or Lamotrigine In Bipolar I Depression
Brief Summary The purpose of this study is to determine if a treatment regimen of ziprasidone plus a mood stabilizer is safe and effective in the short term treatment of Bipolar I Depression. Ziprasidone will be added to lithium, valproate or lamotrigine after the patient has been on a therapeutic dose of one of these mood stabilizers for at least 4 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder
  • Depression, Bipolar
Intervention  ICMJE
  • Drug: Ziprasidone
    Oral capsule formulation to be administered every day for duration of patient's participation in the trial - 40 mg on Day 1; 40 mg twice a day (BID) on Day 2; Flexible BID dosing of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg or 160 mg total daily dose from Day 3 through Week 6. Dose increases of up to 40 mg/day can occur after subject has received previous lower dose for at least 1 day.
    Other Name: Geodon, Zeldox
  • Drug: Placebo
    Matching placebo oral capsules to be administered as per the instructions for the ziprasidone arm
Study Arms  ICMJE
  • Experimental: Ziprasidone
    Active treatment, double-blind, randomized treatment arm
    Intervention: Drug: Ziprasidone
  • Placebo Comparator: Placebo
    Inactive, placebo treatment, double-blind, randomized arm
    Intervention: Drug: Placebo
Publications * Sachs GS, Ice KS, Chappell PB, Schwartz JH, Gurtovaya O, Vanderburg DG, Kasuba B. Efficacy and safety of adjunctive oral ziprasidone for acute treatment of depression in patients with bipolar I disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 Oct;72(10):1413-22. doi: 10.4088/JCP.09m05934.

*   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: January 30, 2009)
298
Original Enrollment  ICMJE
 (submitted: June 5, 2007)
282
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for Bipolar I disorder, most recent episode depressed, with or without rapid cycling and without psychotic features. Subjects receive therapeutic dose of lithium, valproate or lamotrigine for at least 4 weeks prior to randomization.

Exclusion Criteria:

  • Patients with ultra-fast rapid cycling (8 or more mood episodes per year)
  • Significant heart disease including abnormalities in the heart's rhythm (QT prolongation)
  • Psychotic symptoms (hallucinations and/or delusions).
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 Australia,   India,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00483548
Other Study ID Numbers  ICMJE A1281158
Has Data Monitoring Committee Yes
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 February 2010

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