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Adjunctive Ziprasidone in the Treatment of Bipolar I Depression

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Chandler, Arizona, 85226 United States
Contact
1-800-718-1021
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.
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- 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).

NCT00483548
Pfizer
Completed
Adjunctive Ziprasidone in the Treatment of Bipolar I Depression

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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 SummaryThe 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 DescriptionNot 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 DateDecember 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 CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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