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Geodon (Ziprasidone) for Posttraumatic Stress Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00208208
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 15, 2006
Information provided by:
Creighton University

Brief Summary:
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 or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Post-Traumatic Stress Disorder PTSD Drug: Ziprasidone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: Geodon (Ziprasidone) for Posttraumatic Stress Disorder
Study Start Date : December 2002
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00208208

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United States, Nebraska
Creighton University Psychiatry and Research Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
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Principal Investigator: Frederick Petty, MD, PhD Creighton University
Layout table for additonal information Identifier: NCT00208208    
Other Study ID Numbers: 2001-0261
Grant 2001-0261
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 15, 2006
Last Verified: April 2005
Keywords provided by Creighton University:
Posttraumatic Stress Disorder
Post-traumatic Stress Disorder
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents