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| Sponsored by: |
Universitätsklinikum Hamburg-Eppendorf |
|---|---|
| Information provided by: | Universitätsklinikum Hamburg-Eppendorf |
| ClinicalTrials.gov Identifier: | NCT00248261 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Post-Traumatic Stress Disorder |
Drug: ziprasidone, sertraline |
Phase II |
| Study Type: | Observational |
| Study Design: | Psychosocial, Longitudinal, Defined Population, Prospective Study |
| 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) |
| Estimated Enrollment: | 24 |
| Study Start Date: | November 2005 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Michael B Kellner, MD, PhD | 00494042803 ext 2234 | kellner@uke.uni-hamburg.de |
| Contact: Klaus B Wiedemann, MD, PhD | 00494042803 ext 3223 | wiedeman@uke.uni-hamburg.de |
| Germany | |
| UKE, Dept. of Psychiatry and Psychotherapy | Recruiting |
| Hamburg, Germany, 2ß246 | |
| Contact: Michael B Kellner, MD, PhD 00494042803 ext 2234 kellner@uke.uni-hamburg.de | |
| Contact: Klaus B Wiedemann, MD, PhD 00494042803 ext 3223 wiedeman@uke.uni-hamburg.de | |
| Principal Investigator: Michael B Kellner, MD, PhD | |
| Principal Investigator: | Michael B Kellner, MD, PhD | UKE, Dep. of Pschiatry and Psychotherapy, Hamburg, Germany |
More Information
| Study ID Numbers: | ZiSe, NRA1280017 |
| Study First Received: | November 2, 2005 |
| Last Updated: | November 2, 2005 |
| ClinicalTrials.gov Identifier: | NCT00248261 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
ziprasidone, sertraline, PTSD |
|
Neurotransmitter Agents Tranquilizing Agents Psychotropic Drugs Central Nervous System Depressants Stress Antipsychotic Agents Serotonin Uptake Inhibitors Stress Disorders, Traumatic Serotonin |
Dopamine Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic Sertraline Dopamine Agents Ziprasidone Antidepressive Agents |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Stress Disorders, Traumatic Serotonin Antagonists Pathologic Processes Mental Disorders Therapeutic Uses Sertraline Stress Disorders, Post-Traumatic Antidepressive Agents |
Disease Tranquilizing Agents Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Anxiety Disorders Dopamine Agents Ziprasidone Central Nervous System Agents |
