Ziprasidone for the Treatment of Generalized Anxiety in Patients With Bipolar Disorder

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Pfizer
• Treatments: Ziprasidone

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.