You are here

Adjunctive Ziprasidone in the Treatment of Bipolar I Depression

Last updated on August 9, 2018

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.
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).

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Sickle Cell Anemia, Sickle Cell Disease, Sickle Cell Disorders, Pain Crisis, Vaso-occlusive Crisis
NCT02433158
All Genders
6+
Years
Multiple Sites
Obsessive Compulsive Disorder
NCT01302080
All Genders
6+
Years
Multiple Sites
Major Depressive Disorder
NCT02548949
All Genders
19+
Years
Multiple Sites
Adjunctive Ziprasidone in the Treatment of Bipolar I Depression
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Bipolar Disorder
  • Depression, Bipolar
  • 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
  • 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
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.
 
Completed
298
December 2008
December 2008   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   India,   United States
 
 
NCT00483548
A1281158
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now