Ziprasidone and Sertraline in PTSD

• Sponsor: Universitätsklinikum Hamburg-Eppendorf (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00248261
• Collaborator: (none)
• Enrollment: 7
• Location: 1
• Duration (Months): 55
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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	Phase
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 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: Nov 1, 2005
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Jun 1, 2010

Outcome Measures

Primary Outcome Measures

1. Post-Traumatic Diagnostic Scale (PDS) [56 days]

Secondary Outcome Measures

1. Beck Depression Inventory (BDI) [56 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	UKE, Dept. of Psychiatry and Psychotherapy	Hamburg		Germany	2ß246

Sponsors and Collaborators

• Universitätsklinikum Hamburg-Eppendorf

Investigators

• Principal Investigator: Michael B Kellner, MD, PhD, UKE, Dep. of Pschiatry and Psychotherapy, Hamburg, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitätsklinikum Hamburg-Eppendorf
• ClinicalTrials.gov Identifier: NCT00248261
• Other Study ID Numbers: ZiSe; NRA1280017
• First Posted: Nov 3, 2005
• Last Update Posted: Feb 25, 2020
• Last Verified: Feb 1, 2020

• Keywords provided by Universitätsklinikum Hamburg-Eppendorf: ziprasidone, sertraline, PTSD
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Ziprasidone; Sertraline

Study Results

No Results Posted as of Feb 25, 2020