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Ziprasidone and Sertraline in PTSD

This study has been terminated.
(High rate of early drop-outs)
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf Identifier:
First received: November 2, 2005
Last updated: December 12, 2013
Last verified: December 2013
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 Intervention Phase
Post-traumatic Stress Disorder Drug: ziprasidone, sertraline Phase 2

Study Type: Observational
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)

Resource links provided by NLM:

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

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

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

Enrollment: 7
Study Start Date: November 2005
Study Completion Date: June 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
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.

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

  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Universitätsklinikum Hamburg-Eppendorf Identifier: NCT00248261     History of Changes
Other Study ID Numbers: ZiSe
Study First Received: November 2, 2005
Last Updated: December 12, 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 processed this record on September 21, 2017