Status:
COMPLETED
Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder(GAD)
Lead Sponsor:
VA Palo Alto Health Care System
Collaborating Sponsors:
Pfizer
University of South Florida
Conditions:
Bipolar Disorder
Panic Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The specific aim of this study is to evaluate the efficacy, tolerability, and safety of ziprasidone monotherapy in comparison to placebo in the treatment of ambulatory bipolar disorder with co-morbid ...
Detailed Description
This is a randomized, double-blind, placebo controlled, parallel-group, 8-week trial of ziprasidone compared to placebo in outpatient subjects with a lifetime bipolar I, II, or NOS disorder, a lifetim...
Eligibility Criteria
Inclusion
- Subjects must be at least 18 and not older than 65.
- Subjects must have lifetime bipolar I, II, or NOS disorder as defined by DSM-IV TR criteria (26).
- Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV criteria (except clause "does not occur exclusively during a mood disorder" of Criterion F for GAD).
- Subjects' bipolar symptoms must be no more than moderate in severity, defined as a CGI-BP\< 4 (27).
- Subjects' anxiety symptoms must be at least moderate in severity, defined as a CGI-S \> 4 (28).
- Subjects must not be receiving regular mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for at least one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for at least four weeks prior to baseline.
- Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained.
- If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01172652
Start Date
April 1 2010
End Date
October 1 2011
Last Update
April 8 2025
Active Locations (3)
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1
VA Palo Alto Health Care System & Stanford School of Medicine
Palo Alto, California, United States, 94304
2
University of South Florida Institute for Research in Psychiatry
Tampa, Florida, United States, 33613
3
Lindner Center of Hope University of Cincinnati Medical Center
Mason, Ohio, United States, 45040