Ziprasidone and Sertraline in PTSD
Information source: Universitätsklinikum Hamburg-Eppendorf
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-Traumatic Stress Disorder
Intervention: ziprasidone, sertraline (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Universitätsklinikum Hamburg-Eppendorf Official(s) and/or principal investigator(s):
Michael B Kellner, MD, PhD, Principal Investigator, Affiliation: UKE, Dep. of Pschiatry and Psychotherapy, Hamburg, Germany
Overall contact:
Michael B Kellner, MD, PhD, Phone: 00494042803, Ext: 2234, Email: kellner@uke.uni-hamburg.de
Summary
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.
Clinical Details
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)
Study design: Psychosocial, Longitudinal, Defined Population, Prospective Study
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Michael B Kellner, MD, PhD, Phone: 00494042803, Ext: 2234, Email: kellner@uke.uni-hamburg.de
UKE, Dept. of Psychiatry and Psychotherapy, Hamburg 2ß246, Germany; Recruiting
Michael B Kellner, MD, PhD, Phone: 00494042803, Ext: 2234, Email: kellner@uke.uni-hamburg.de
Klaus B Wiedemann, MD, PhD, Phone: 00494042803, Ext: 3223, Email: wiedeman@uke.uni-hamburg.de
Michael B Kellner, MD, PhD, Principal Investigator
Additional Information
Starting date: November 2005
Last updated: November 2, 2005
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