3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar Disorder

In brief

3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects

Key facts

Study ID

NCT00312494

Run by

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

People needed

680

Starts

2006-04-01

Expected to finish

2008-12-01

Last updated by the study team

2021-03-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode manic (296.4x), or mixed (296.6x) as defined in Diagnostic and Statistical Manual of Mental Disorders - Text Revision (DSM-IV TR) and determined by the Mini International Neuropsychiatric Interview (MINI).
• At screening and at baseline (within 12 hours prior to the first dose of double-blind medication) subjects must have a Young Mania Rating Scale score of 18 or higher.
• Subjects must be actively receiving lithium or divalproex for their bipolar disorder in order to be considered for this study.

You may not qualify if…

• Subjects with a Diagnostic and Statistical Manual of Mental Disorders IV- Text Revision (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 (NOS) (298.9).
• Subjects with other DSM-IV-TR Axis I or Axis II disorders (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 — Scottsdale, Arizona, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — Cerritos, California, United States
• Pfizer Investigational Site — Costa Mesa, California, United States
• Pfizer Investigational Site — Escondido, California, United States
• Pfizer Investigational Site — Glendale, California, United States
• Pfizer Investigational Site — Huntington Beach, California, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — National City, California, United States
• Pfizer Investigational Site — Oceanside, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Torrance, California, United States
• Pfizer Investigational Site — Hartford, Connecticut, United States
• Pfizer Investigational Site — New Britain, Connecticut, United States
• Pfizer Investigational Site — DeLand, Florida, United States
• Pfizer Investigational Site — Fort Lauderdale, Florida, United States
• Pfizer Investigational Site — Fort Lauderdale, Florida, United States
• Pfizer Investigational Site — Gainesville, Florida, United States
• Pfizer Investigational Site — Hollywood, Florida, United States
• Pfizer Investigational Site — Jacksonville, Florida, United States
• Pfizer Investigational Site — Lauderhill, Florida, United States
• Pfizer Investigational Site — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.