ABOUT THIS STUDY
- Male and female outpatients, aged 18 to 75 years.
- Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II).
- Current diagnosis of Generalized Anxiety Disorder (GAD).
- Participants must be on at least one of the following mood stabilizers at steady dose for at least 4 weeks prior to randomization: lithium with blood levels between 0.4-1.4 meq/L, valproic acid/divalproate sodium (with levels between 50-150 ugm/dl) carbamazepine (blood levels between 4-12 mcg/ml), or lamotrigine (dosed 50-400 mg/day).
- Pregnant or lactating women or others not using acceptable means of birth control
(e.g., IUD, oral contraceptives, barrier devices, condoms and foam, implanted
progesterone rods stabilized for at least 3 months).
- Patients with current or history of schizophrenia, or patients with current mania,
hypomania at study entry. Lifetime psychosis and dementia are exclusionary.
- Patients with current obsessive-compulsive disorder or posttraumatic stress disorder
- Patients with a history of alcohol or substance abuse or dependence within the last
- Patients with significant unstable medical illness likely to result in hospitalization
or acute medical care. In addition, patients with an established diagnosis of diabetes
mellitus are excluded.
- Current cognitive behavioral therapy directed toward the treatment of generalized
- History of hypersensitivity to or lack of response to ziprasidone.
- Concomitant treatment with other typical or atypical antipsychotics; patients should
be off other typical or atypical antipsychotics for at least one week prior to study
- Patients with significant suicidal ideation or who have enacted suicidal behaviors
within 3 months prior to intake will be excluded from study participation and referred
for appropriate clinical intervention.
- Patients who have had a psychiatric hospitalization (including for bipolar disorder)
in the past 3 months are excluded.
- Seizure disorders with the exception of a history of febrile seizures if they occurred
during childhood, were isolated, and did not recur in adulthood.
- History of Neuroleptic Malignant Syndrome.
- Individuals with current clinically significant orthostatic hypotension are excluded.
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- Boston, Massachusetts