Ziprasidone and Sertraline in PTSD
Serotonine re-uptake inhibitors, such as sertraline, are the medication of choice in post-traumatic stress disorder. However, it takes several weeks before they ameliorate symptoms. Therefore, we will add ziprasidone (vs. placebo) medication during the first four weeks of sertraline in order to find out if this strategy accelerates symptomatic relief...
Brief Summary
Official Title: “Effects of Ziprasidone Vs. Placebo During the First Four Weeks of Eight Weeks Sertraline Treatment in Patients With Post-Traumatic Stress Disorder (PTSD)”
Serotonine re-uptake inhibitors, such as sertraline, are the medication of choice in post-traumatic stress disorder. However, it takes several weeks before they ameliorate symptoms. Therefore, we will add ziprasidone (vs. placebo) medication during the first four weeks of sertraline in order to find out if this strategy accelerates symptomatic relief.
- Study Type: Observational
- Study Design: Additional Descriptors: Psychosocial, Observational Model: Defined Population, Time Perspective: Longitudinal, Time Perspective: Prospective
Detailed Clinical Trial Description
A current problem in the pharmacotherapy of PTSD is that the medication of choice, serotonin re-uptake inhibitors, take several weeks before they show considerable effects on PTSD symptoms. Addition of typical neuroleptics, such as ziprasidone, offers a potential strategy to bring about a faster symptomatic relief, because they display anxiolytic properties without the risk of dependence. Therefore, in addition to standard sertraline therapy (at least 8 weeks), we will give ziprasidone vs. placebo over the first four weeks in a double-blind randomized design.
Intervention(s) in this Clinical Trial
- Drug: ziprasidone, sertraline
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Clinical diagnosis of Post-Traumatic Stress Disorder
Exclusion Criteria:
- Lifetime psychotic disorders, current substance dependency, gravidity, lactation, tartrazine hypersensitivity, contraindication against sertraline or ziprasidone
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Universitätsklinikum Hamburg-Eppendorf Other
Overall Clinical Trial Officials and Contacts
Michael B Kellner, MD, PhD Principal Investigator UKE, Dep. of Pschiatry and Psychotherapy, Hamburg, Germany
Overall Contact: Michael B Kellner, MD, PhD 00494042803 kellner@uke.uni-hamburg.de
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00248261
Study ID Number: ZiSe
ClinicalTrials.gov Identifier: NCT00248261
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00248261
