Ziprasidone for the Treatment of Generalized Anxiety in Patients With Bipolar Disorder
Condition: Generalized Anxiety Disorder; Bipolar Disorder
MeSH terms: Anxiety Disorders; Bipolar Disorder
Intervention: Ziprasidone; Placebo
Intervention description: Ziprasidone, flexibly dosed from 40 to 160 mg/day, for 8 weeks.; Placebo administered daily for 8 weeks
Intervention MeSH terms: Ziprasidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Bipolar Disorder; Generalized Anxiety Disorder; Double-blind; Placebo-controlled; Ziprasidone

Summary:

      This study proposes to examine the potential safety and efficacy of ziprasidone for patients
      with anxiety and bipolar disorder on anxiety outcomes, bipolar symptoms, and on measures of
      quality of life and resilience.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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).

        Exclusion Criteria:

          -  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
             are excluded.

          -  Patients with a history of alcohol or substance abuse or dependence within the last
             three months.

          -  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
             anxiety disorder.

          -  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
             baseline.

          -  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.