Geodon (Ziprasidone) for Posttraumatic Stress Disorder

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Creighton University
ClinicalTrials.gov Identifier:
NCT00208208
First received: September 14, 2005
Last updated: September 14, 2006
Last verified: April 2005
  Purpose

Atypical antipsychotics have shown promise in the treatment of depression and anxiety, which are prominent symptoms of PTSD. The profile of the atypical antipsychotic, ziprasidone (Geodon), suggests possible anxiolytic and antidepressant properties. This research will assess the potential effectiveness of Geodon in civilian men and women who suffer from severe PTSD. Response to ziprasidone or placebo will be measured by Clinician Administered PTSD Scale (CAPS) and Treatment Outcomes PTSD Scale (TOP-8).


Condition Intervention Phase
Posttraumatic Stress Disorder
Post-Traumatic Stress Disorder
PTSD
Drug: Ziprasidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: Geodon (Ziprasidone) for Posttraumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Response to ziprasidone or placebo (inactive drug) will be measured by Clinician Administered PTSD Scale (CAPS) and Treatment Outcomes PTSD Scale (TOP-8).

Secondary Outcome Measures:
  • A secondary aim of the study is to measure effects on depression and anxiety symptoms in the same persons, using the HAM-A, HAM-D and the CGI. Quality of life will also be assessed using the QOLI.

Estimated Enrollment: 80
Study Start Date: December 2002
Estimated Study Completion Date: April 2005
Detailed Description:

PTSD is a common disorder with 10% lifetime prevalence among Americans. The major causes of PTSD are sexual assault, accidents, disasters Despite this public health burden, only two drugs, sertraline (Zoloft) and paroxetine (Paxil), are approved by the FDA for the treatment of PTSD. New options for the treatment of PTSD are much needed. Approximately half of patients with PTSD respond to Zoloft and Paxil. Many patients experience psychotic symptoms with PTSD, which may not respond to treatment to Zoloft and Paxil.

Though classified as an anxiety disorder in the DSM-IV, PTSD is accompanied by psychotic symptoms in almost half of patients (Butler et al 1996; Hamner et al 1999, Lindley et al 2000). Also, PTSD has an extensive comorbidity with major depressive disorder (Davis et al 2000). While Geodon is approved by the FDA in the United States for the treatment of psychosis, it has not been evaluated for the treatment of PTSD . A clinical trial of Geodon in PTSD will help delineate the potential antidepressant spectrum of efficacy of Geodon as well as its anxiolytic profile.

  Eligibility

Ages Eligible for Study:   19 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men & women with DSM-IV clinical diagnosis of PTSD who are able to attend weekly clinic appointments
  • Age 19-64, not pregnant and either sterile or using a medically acceptable method of birth control
  • A willingness and ability to provide competent signed informed consent
  • A level of understanding sufficient to perform all tests and examinations required by the protocol (including fluency of spoken English)

Exclusion Criteria:

  • Any diagnosis of schizophrenia or bipolar I disorder, or active substance dependence
  • Unstable general medical condition or serious illness (e.g.. death or hospitalization is anticipated within one year), poor kidney function, liver function (defined as lab values ≥ three times the upper limit of the laboratory normal) and seizure disorders with the exception of childhood seizure disorders.
  • Subjects with prior non-response to Geodon for the treatment of PTSD with an adequate trial
  • Enrollment in any study drug within the last 30 days. Current pharmacotherapy is permitted, provided that the medication and dose have been stable for the past 90 days.
  • Pregnancy or nursing
  • Any subject judged clinically to be at serious suicidal risk in the opinion of the investigator
  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: NCT00208208

Locations
United States, Nebraska
Creighton University Psychiatry and Research Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Pfizer
Investigators
Principal Investigator: Frederick Petty, MD, PhD Creighton University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00208208     History of Changes
Other Study ID Numbers: 2001-0261, Grant 2001-0261
Study First Received: September 14, 2005
Last Updated: September 14, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
Posttraumatic Stress Disorder
Post-traumatic Stress Disorder
PTSD
Geodon
Ziprasidone

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 20, 2014