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Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder(GAD) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder(GAD)

A Randomized, Double-Blind, Placebo-Controlled Study of Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder

NCT01172652•VA Palo Alto Health Care System

View on ClinicalTrials.gov

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.

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 lifetime panic or generalized anxiety disorder, and current diagnosis at least moderately severe anxiety symptoms. Approximately 50 subjects will be randomized. Subjects will be randomized to ziprasidone or placebo in a 1:1 ratio. No concomitant psychotropic medication will be allowed throughout the study except for prn lorazepam during the first two weeks for the management of affective and anxiety symptoms, prn zolpidem and zaleplon for the management of insomnia and benztropine for the management of EPS. Throughout the study, psychiatric scales will be used to assess psychiatric symptoms and the presence of treatment-emergent adverse events will be monitored and recorded.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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).
•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.
+12 more criteria

Locations (3)

VA Palo Alto Health Care System & Stanford School of Medicine

Palo Alto, California, United States

University of South Florida Institute for Research in Psychiatry

Tampa, Florida, United States

Lindner Center of Hope University of Cincinnati Medical Center

Mason, Ohio, United States

Key Dates

Start Date

April 1, 2010

Primary Completion Date

October 1, 2011

Completion Date

October 1, 2011

Last Updated

April 8, 2025

Enrollment

ACTUAL participants

Conditions

Bipolar DisorderPanic DisorderGeneralized Anxiety Disorder

Interventions

Ziprasidone

DRUG

Placebo

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder(GAD)

Inclusion Criteria

Exclusion Criteria

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