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

This study has been completed.
Sponsor:
Collaborators:
Pfizer
University of South Florida
Lindner Center of HOPE
Information provided by (Responsible Party):
patricia suppes, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier:
NCT01172652
First received: April 16, 2010
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Panic Disorder
Generalized Anxiety Disorder
Drug: Ziprasidone
Drug: Placebo
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by VA Palo Alto Health Care System:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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).


Enrollment: 49
Study Start Date: April 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ziprasidone Drug: Ziprasidone
The minimum dose during study participation will be 40 mg/day, and the maximum dose allowed will be 160 mg/day.
Other Names:
  • Geodon
  • Zeldox
Placebo Comparator: Placebo Drug: Placebo
Inactive control
Other Name: sugar pill

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must at least age of 18 years of age 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 generalized anxiety disorder 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 including hepatic, renal, respiratory, cardiovascular, endocrine, neurological, or hematological disease 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 patient's 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172652

Locations
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
Sponsors and Collaborators
VA Palo Alto Health Care System
Pfizer
University of South Florida
Lindner Center of HOPE
Investigators
Principal Investigator: Trisha Suppes, MD, PhD VA Palo Alto Health Care System & Stanford School of Medicine
  More Information

Additional Information:
No publications provided by VA Palo Alto Health Care System

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: patricia suppes, Director, Bipolar and Depression Research Program, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT01172652     History of Changes
Other Study ID Numbers: SUP0005-17504
Study First Received: April 16, 2010
Last Updated: March 16, 2012
Health Authority: United States: Federal Government

Keywords provided by VA Palo Alto Health Care System:
Bipolar disorder
Anxiety
Panic
GAD
Generalized Anxiety Disorder

Additional relevant MeSH terms:
Anxiety Disorders
Bipolar Disorder
Disease
Panic Disorder
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes
Ziprasidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 29, 2014