Geodon (Ziprasidone) for Posttraumatic Stress Disorder
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|ClinicalTrials.gov Identifier: NCT00208208|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 15, 2006
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder Post-Traumatic Stress Disorder PTSD||Drug: Ziprasidone||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Geodon (Ziprasidone) for Posttraumatic Stress Disorder|
|Study Start Date :||December 2002|
|Study Completion Date :||April 2005|
- Response to ziprasidone or placebo (inactive drug) will be measured by Clinician Administered PTSD Scale (CAPS) and Treatment Outcomes PTSD Scale (TOP-8).
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT00208208
|United States, Nebraska|
|Creighton University Psychiatry and Research Center|
|Omaha, Nebraska, United States, 68131|
|Principal Investigator:||Frederick Petty, MD, PhD||Creighton University|