Status:
TERMINATED
Ziprasidone for the Treatment of Generalized Anxiety in Patients With Bipolar Disorder
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Pfizer
Conditions:
Generalized Anxiety Disorder
Bipolar Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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...
Detailed Description
This study would be the first prospective, placebo-controlled study to our knowledge of any pharmacotherapy strategy for the treatment of comorbid generalized anxiety (or any comorbid anxiety) in pati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00374543
Start Date
February 1 2006
End Date
November 1 2008
Last Update
April 16 2014
Active Locations (1)
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1
Center for Anxiety and Traumatic Stress Disorders at Massachusetts General Hospital
Boston, Massachusetts, United States, 02114