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 medication. Subjects who continue to meet entry criteria will then undergo a 1-day baseline period during which baseline assessments will be obtained. Subjects will then be randomly assigned to either a ziprasidone arm (20-40 mg bid or 60-80 mg bid) or placebo treatment.

Condition	Intervention	Phase
Bipolar Disorder	Drug: Geodon (Ziprasidone)	Phase III

Further Study Details: 

Primary Outcomes: The primary objective of this study will be to compare the efficacy of ziprasidone to placebo over a 6-week course of treatment in outpatients with a diagnosis of Bipolar Disorder Type I, depressed, with or without rapid cycling, who have a HAM-D-17 scor
Secondary Outcomes: The main secondary objectives of this study will be:1.To evaluate efficacy in depressive symptoms using the HAM-D-17 and the HAM-D-252.To evaluate improvement in anxiety symptoms using the HAM-A3.To evaluate the incidence of manic symptoms and/or switch
Expected Total Enrollment:  540

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00141271

David Pearson      212-733-3431    david.pearson@pfizer.com

California
      Pfizer Investigational Site, Torrance,  California,  90505,  United States; Recruiting
Florida
      Pfizer Investigational Site, North Miami,  Florida,  33161,  United States; Recruiting
Indiana
      Pfizer Investigational Site, Lafayette,  Indiana,  47905,  United States; Recruiting
Texas
      Pfizer Investigational Site, Wichita Falls,  Texas,  76309,  United States; Recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A1281136
Last Updated:  August 31, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00141271
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06