Ziprasidone and Sertraline in PTSD
Serotonin 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 Design:||Observational Model: Case-Only
Time Perspective: Prospective
|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)|
- Post-Traumatic Diagnostic Scale (PDS) [ Time Frame: 56 days ] [ Designated as safety issue: No ]
- Beck Depression Inventory (BDI) [ Time Frame: 56 days ] [ Designated as safety issue: No ]
|Study Start Date:||November 2005|
|Study Completion Date:||June 2010|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248261
|UKE, Dept. of Psychiatry and Psychotherapy|
|Hamburg, Germany, 2ß246|
|Principal Investigator:||Michael B Kellner, MD, PhD||UKE, Dep. of Pschiatry and Psychotherapy, Hamburg, Germany|