Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder(GAD) (Pfizer Anxiety)
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.
Generalized Anxiety Disorder
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study of Ziprasidone in Bipolar Disorder With Comorbid Lifetime Panic or Generalized Anxiety Disorder|
- CGI-21 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]The primary outcome measure is the Clinician Global Improvement Scale for Anxiety Symptoms (CGI-21)
- Sheehan Panic Disorder Scale (SPS), (HAM-A), Young Mania Rating Scale (YMRS), Sheehan Irritability Scale (SIS), Rapid Ideas Scale RISC, MADRS, PGI-21 symptoms, CGI-BP, Family Impact Scale (FIS), Sheehan Disability Scale (SDS). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Sheehan Panic Disorder Scale (SPS), (HAM-A), Young Mania Rating Scale (YMRS), Sheehan Irritability Scale (SIS), Rapid Ideas Scale RISC, MADRS, PGI-21 for anxiety symptoms, CGI-BP, Family Impact Scale (FIS), Sheehan Disability Scale (SDS).
|Study Start Date:||April 2010|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
The minimum dose during study participation will be 40 mg/day, and the maximum dose allowed will be 160 mg/day.
|Placebo Comparator: Placebo||
Other Name: sugar pill
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.
|United States, California|
|VA Palo Alto Health Care System & Stanford School of Medicine|
|Palo Alto, California, United States, 94304|
|United States, Florida|
|University of South Florida Institute for Research in Psychiatry|
|Tampa, Florida, United States, 33613|
|United States, Ohio|
|Lindner Center of Hope University of Cincinnati Medical Center|
|Mason, Ohio, United States, 45040|
|Principal Investigator:||Trisha Suppes, MD, PhD||VA Palo Alto Health Care System & Stanford School of Medicine|