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Sponsors and Collaborators: |
Creighton University Pfizer |
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Information provided by: | Creighton University |
ClinicalTrials.gov Identifier: | NCT00208208 |
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 |
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Posttraumatic Stress Disorder Post-Traumatic Stress Disorder PTSD |
Drug: Ziprasidone |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Geodon (Ziprasidone) for Posttraumatic Stress Disorder |
Estimated Enrollment: | 80 |
Study Start Date: | December 2002 |
Estimated Study Completion Date: | April 2005 |
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.
Ages Eligible for Study: | 19 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Nebraska | |
Creighton University Psychiatry and Research Center | |
Omaha, Nebraska, United States, 68131 |
Principal Investigator: | Frederick Petty, MD, PhD | Creighton University |
Study ID Numbers: | 2001-0261, Grant 2001-0261 |
Study First Received: | September 14, 2005 |
Last Updated: | September 14, 2006 |
ClinicalTrials.gov Identifier: | NCT00208208 History of Changes |
Health Authority: | United States: Institutional Review Board |
Posttraumatic Stress Disorder Post-traumatic Stress Disorder PTSD Geodon Ziprasidone |
Neurotransmitter Agents Tranquilizing Agents Psychotropic Drugs Stress Central Nervous System Depressants Antipsychotic Agents Stress Disorders, Traumatic |
Serotonin Dopamine Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic Dopamine Agents Ziprasidone |
Neurotransmitter Agents Tranquilizing Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Stress Dopamine Antagonists Antipsychotic Agents Stress Disorders, Traumatic |
Pharmacologic Actions Serotonin Antagonists Pathologic Processes Serotonin Agents Anxiety Disorders Mental Disorders Therapeutic Uses Stress Disorders, Post-Traumatic Dopamine Agents Ziprasidone Central Nervous System Agents |