A Six-Week Study Evaluating The Efficacy And Safety Of Geodon In Patients With A Diagnosis Of 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

NCT00141271

Run by

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

People needed

536

Starts

2005-07-01

Expected to finish

2008-02-01

Last updated by the study team

2021-03-25

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 Diagnostic and Statistical Manual (of Mental Disorders) - Fourth Edition - Text Revision (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 not otherwise specified (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 — Dana Point, California, United States
• Pfizer Investigational Site — La Mesa, California, United States
• Pfizer Investigational Site — Laguna Hills, California, United States
• Pfizer Investigational Site — Oceanside, California, United States
• Pfizer Investigational Site — Orange, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Santa Ana, California, United States
• Pfizer Investigational Site — Torrance, California, United States
• Pfizer Investigational Site — Fort Lauderdale, Florida, United States
• Pfizer Investigational Site — Gainesville, Florida, United States
• Pfizer Investigational Site — Hialeah, Florida, United States
• Pfizer Investigational Site — Jacksonville, Florida, United States
• Pfizer Investigational Site — North Miami, Florida, United States
• Pfizer Investigational Site — Orlando, Florida, United States
• Pfizer Investigational Site — Winter Park, Florida, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Maywood, Illinois, United States
• Pfizer Investigational Site — Naperville, Illinois, United States
• Pfizer Investigational Site — Schaumburg, Illinois, United States
• Pfizer Investigational Site — Greenwood, Indiana, United States
• Pfizer Investigational Site — Lafayette, Indiana, United States
• Pfizer Investigational Site — Prarie Village, Kansas, United States
• Pfizer Investigational Site — New Orleans, Louisiana, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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