Ziprasidone and Sertraline in PTSD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00248261
Recruitment Status : Terminated (High rate of early drop-outs)
First Posted : November 3, 2005
Last Update Posted : December 13, 2013
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
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.

Condition or disease Intervention/treatment
Post-traumatic Stress Disorder Drug: ziprasidone, sertraline

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.

Study Type : Observational
Actual Enrollment : 7 participants
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)
Study Start Date : November 2005
Actual Primary Completion Date : August 2009
Actual Study Completion Date : June 2010

Primary Outcome Measures :
  1. Post-Traumatic Diagnostic Scale (PDS) [ Time Frame: 56 days ]

Secondary Outcome Measures :
  1. Beck Depression Inventory (BDI) [ Time Frame: 56 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
PTSD patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00248261

UKE, Dept. of Psychiatry and Psychotherapy
Hamburg, Germany, 2ß246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Principal Investigator: Michael B Kellner, MD, PhD UKE, Dep. of Pschiatry and Psychotherapy, Hamburg, Germany

Responsible Party: Universitätsklinikum Hamburg-Eppendorf Identifier: NCT00248261     History of Changes
Other Study ID Numbers: ZiSe
First Posted: November 3, 2005    Key Record Dates
Last Update Posted: December 13, 2013
Last Verified: December 2013

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
ziprasidone, sertraline, PTSD

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Serotonin Antagonists
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Dopamine Antagonists
Dopamine Agents