PTSD Clinical Trial
Official title:
Geodon (Ziprasidone) for Posttraumatic Stress Disorder
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).
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic
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