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| Sponsor: | 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: | Additional Descriptors: Psychosocial Observational Model: Defined Population Time Perspective: Longitudinal 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) |
| 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
| ClinicalTrials.gov Identifier: | NCT00248261 History of Changes |
| Other Study ID Numbers: | ZiSe, NRA1280017 |
| Study First Received: | November 2, 2005 |
| Last Updated: | November 2, 2005 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
ziprasidone, sertraline, PTSD |
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders Sertraline Ziprasidone Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Serotonin Antagonists Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Dopamine Antagonists Dopamine Agents |
