Adjunctive Ziprasidone in the Treatment of Bipolar I Depression

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar Disorder, Depression, Bipolar

In brief

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.

Key facts

Study ID

NCT00483548

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

298

Starts

2007-10-01

Expected to finish

2008-12-01

Last updated by the study team

2021-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Pfizer Investigational Site — Litchfield Park, Arizona, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — Springdale, Arkansas, United States
• Pfizer Investigational Site — Costa Mesa, California, United States
• Pfizer Investigational Site — Oceanside, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Torrance, California, United States
• Pfizer Investigational Site — Boca Raton, Florida, United States
• Pfizer Investigational Site — Boca Raton, Florida, United States
• Pfizer Investigational Site — Jacksonville, Florida, United States
• Pfizer Investigational Site — Orlando, Florida, United States
• Pfizer Investigational Site — Sanford, Florida, United States
• Pfizer Investigational Site — St. Petersburg, Florida, United States
• Pfizer Investigational Site — West Palm Beach, Florida, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Skokie, Illinois, United States
• Pfizer Investigational Site — Greenwood, Indiana, United States
• Pfizer Investigational Site — Indianapolis, Indiana, United States
• Pfizer Investigational Site — Topeka, Kansas, United States
• Pfizer Investigational Site — Wichita, Kansas, United States
• Pfizer Investigational Site — Lake Charles, Louisiana, United States
• Pfizer Investigational Site — Rockville, Maryland, United States
• Pfizer Investigational Site — Boston, Massachusetts, United States
• Pfizer Investigational Site — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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