Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder(GAD)

Exclusion Criteria

• •Subjects who do not have lifetime bipolar disorder by DSM-IV-TR criteria (26).
• •Subjects who do not have lifetime panic disorder or GAD by DSM-IV-TR criteria (26).
• •Subjects who are receiving treatment with an anti-manic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication.
• •Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP \> 5) (27).
• •Subjects whose anxiety symptoms are presently less than moderately severe (CGI-S \< 3) (28).
• •Subjects with clinically significant suicidal or homicidal ideation.
• •Subjects with a current DSM-IV TR Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV TR diagnosis of a substance dependence disorder within the past six months; a lifetime DSM-IV TR psychotic disorder (e.g., schizophrenia or schizoaffective disorder).
• •Subjects with serious general medical illnesses as determined by the clinical judgment of the clinical investigator. Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement \> 3 months.
• •Subjects with a clinically significant abnormality in their pre-study physical exam, vital signs, EKG, or laboratory tests.
• •Subjects who are allergic to or who have demonstrated hypersensitivity or intolerance to ziprasidone.
• •Women who are pregnant or nursing.
• •Subjects who have received an experimental drug or used an experimental device within 30 days.
• •Subjects who have a history of neuroleptic malignant syndrome.
• •A patient with diabetes mellitus (DM) fulfilling one of the following criteria:
• •* Unstable DM defined as enrollment glycosylated hemoglobin (HbAlc) \>8.5%
• •* Admitted to hospital for treatment of DM or DM related illness within the past 12 weeks
• •* Not under physician care for DM
• •* Physician responsible for patient's DM care has not indicated that the DM is controlled
• •* Physician responsible for patient's DM care has not approved the patient's participation in the study
• •* Has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks before randomization. For thiazolidinediones(glitazones)this period should not be less than 8 weeks before randomization.
• •* Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks
• •Note: If a patient with DM meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study