Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder(GAD) (NCT01172652) | Clinical Trial Compass
CompletedPhase 4
Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder(GAD)
United States49 participantsStarted 2010-04
Plain-language 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 lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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).
* Subj…