A Six-week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression.

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar Disorder

In brief

This is a 6-week trial that evaluates the efficacy and safety of Geodon (ziprasidone) in outpatient subjects ages 18 and older with Bipolar Disorder type I, depressed. Subjects are required to undergo a washout period of at least 7 days of any prior med.

Key facts

Study ID

NCT00282464

Run by

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

People needed

392

Starts

2006-02-01

Expected to finish

2008-03-01

Last updated by the study team

2021-03-29

Who can join

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

You may qualify if…

• Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode depressed, with or without rapid cycling, without psychotic features, as defined in DSM-IV-TR (296.5X) and confirmed by a structured Mini International Neuropsychiatric Interview (MINI)

You may not qualify if…

• Subjects with a DSM-IV TR diagnosis of schizophrenia (295.XX), schizoaffective disorder (295.70), schizophreniform disorder (295.40), delusional disorder (297.1), or psychotic disorder NOS (298.9).
• Subjects with other DSM-IV TR Axis I or Axis II disorder (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.

Where it is running

• Pfizer Investigational Site — Dothan, Alabama, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — Anaheim, California, United States
• Pfizer Investigational Site — Cerritos, California, United States
• Pfizer Investigational Site — Chula Vista, California, United States
• Pfizer Investigational Site — Escondido, California, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Riverside, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Santa Ana, California, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — Darien, Connecticut, United States
• Pfizer Investigational Site — Boca Raton, Florida, United States
• Pfizer Investigational Site — Bradenton, Florida, United States
• Pfizer Investigational Site — Jacksonville, Florida, United States
• Pfizer Investigational Site — Melbourne, Florida, United States
• Pfizer Investigational Site — Orange City, Florida, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Marietta, Georgia, United States
• Pfizer Investigational Site — Eagle, Idaho, United States
• Pfizer Investigational Site — Granite City, Illinois, United States
• Pfizer Investigational Site — Terre Haute, Indiana, United States
• Pfizer Investigational Site — Glen Burnie, Maryland, United States
• Pfizer Investigational Site — Towson, Maryland, United States

Full record on ClinicalTrials.gov

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