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

Bipolar Disorder Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anxiety Disorders
• Bipolar Disorder
• Disease
• Generalized Anxiety Disorder
• Panic Disorder

• NCT number: NCT01172652
• Study type: Interventional
• Source: VA Palo Alto Health Care System
• Status: Completed
• Phase: Phase 4
• Start date: April 2010
• Completion date: October 2011