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3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects

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ClinicalTrials.gov Identifier: NCT00312494
Recruitment Status : Completed
First Posted : April 10, 2006
Results First Posted : January 22, 2010
Last Update Posted : February 18, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE April 6, 2006
First Posted Date  ICMJE April 10, 2006
Results First Submitted Date  ICMJE December 17, 2009
Results First Posted Date  ICMJE January 22, 2010
Last Update Posted Date February 18, 2010
Study Start Date  ICMJE April 2006
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2009)
Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS) [ Time Frame: Baseline, Week 3 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2006)
  • The primary objective of the study is to compare the efficacy of add-on ziprasidone
  • to placebo, in subjects treated with either lithium or divalproex, at the end of a 3-
  • week course of treatment. At screening and at baseline, subjects must have a
  • Young Mania Rating Scale score of 18 or higher. The primary efficacy measure
  • will be the Young Mania Rating Scale (YMRS).
Change History Complete list of historical versions of study NCT00312494 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2009)
  • Change From Baseline to Week 1 and Week 2 in YMRS [ Time Frame: Baseline, Week 1, Week 2 ]
  • Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Scores [ Time Frame: Baseline, Week 1, Week 2, Week 3 ]
  • Change From Baseline in Clinical Global Impression Scale - Severity (CGI-S) Score [ Time Frame: Baseline, Week 1, Week 2, Week 3 ]
  • Clinical Global Impression - Improvement (CGI-I) Scale Scores [ Time Frame: Week 1, Week 2, Week 3 ]
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score [ Time Frame: Baseline, Week 3 ]
  • Change From Baseline in Global Assessment of Functioning (GAF) Score [ Time Frame: Baseline, Week 3 ]
  • Change From Baseline in Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning (LIFE-RIFT) Score [ Time Frame: Baseline, Week 3 ]
  • Anonymized Pharmacogenomic Blood Draw [ Time Frame: Baseline ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2006)
  • To evaluate improvement in depressive symptoms using the Montgomery Asberg
  • Depression Rating Scale (MADRS)
  • To evaluate improvement in overall psychopathology using the Positive and
  • Negative Syndrome Scale (PANSS)
  • To evaluate improvement in global clinical severity and improvement of symptoms
  • using the Clinical Global Impression Scale (CGI-Severity) and (CGI-Improvement)
  • To evaluate global functioning using the Global Assessment of Functioning (GAF) and Range of Impaired
  • Functioning Tool (LIFE-RIFT).
  • To evaluate the pharmacogenomic basis for ziprasidone treatment responsivity
  • anonymized pharmacogenomic blood draw).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects
Official Title  ICMJE A Three-Week, Double-Blind, Multicenter, Placebo-Controlled Study Evaluating the Efficacy and Safety of Add-On Oral Ziprasidone in Subjects With Acute Mania Treated With Lithium or Divalproex
Brief Summary 3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects
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
Intervention  ICMJE
  • Drug: Placebo
    Placebo with mood stabilizer (either lithium or divalproex)
  • Drug: Ziprasidone
    Flexible dosing, 20-40mg BID, with a mood stabilizer (either lithium or divalproex)
    Other Name: Geodon, Zeldox
  • Drug: Ziprasidone
    Flexible dosing, 60-80mg BID, with a mood stabilizer (either lithium or divalproex)
    Other Name: Geodon, Zeldox
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Ziprasidone 20-40mg twice a day (BID)
    Intervention: Drug: Ziprasidone
  • Experimental: Ziprasidone 60-80mg BID
    Intervention: Drug: Ziprasidone
Publications *

*   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 16, 2009)
680
Original Enrollment  ICMJE
 (submitted: April 6, 2006)
405
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:

  • Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode manic (296.4x), or mixed (296.6x) as defined in Diagnostic and Statistical Manual of Mental Disorders - Text Revision (DSM-IV TR) and determined by the Mini International Neuropsychiatric Interview (MINI).
  • At screening and at baseline (within 12 hours prior to the first dose of double-blind medication) subjects must have a Young Mania Rating Scale score of 18 or higher.
  • Subjects must be actively receiving lithium or divalproex for their bipolar disorder in order to be considered for this study.

Exclusion Criteria:

  • Subjects with a Diagnostic and Statistical Manual of Mental Disorders IV- Text Revision (DSM-IV TR) diagnosis of schizophrenia (295.XX), schizoaffective disorder (295.70), schizophreniform disorder (295.40), delusional disorder (297.1), or psychotic disorder not otherwise specified (NOS) (298.9).
  • Subjects with other DSM-IV-TR Axis I or Axis II disorders (in addition to Bipolar I disorder) are ineligible if the comorbid condition is clinically unstable, requires treatment, or has been a primary focus of treatment within the 6-month period prior to screening.
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 NCT00312494
Other Study ID Numbers  ICMJE A1281143
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 Center Pfizer
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