Ziprasidone and Sertraline in PTSD

NCT ID: NCT00248261

Last Updated: 2020-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-11-30

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Post-traumatic Stress Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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ziprasidone, sertraline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael B Kellner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UKE, Dep. of Pschiatry and Psychotherapy, Hamburg, Germany

Locations

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UKE, Dept. of Psychiatry and Psychotherapy

Hamburg, , Germany

Site Status

Countries

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Germany

References

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Kellner M, Muhtz C, Wiedemann K. Primary add-on of ziprasidone in sertraline treatment of posttraumatic stress disorder: lessons from a stopped trial? J Clin Psychopharmacol. 2010 Aug;30(4):471-3. doi: 10.1097/JCP.0b013e3181e79600. No abstract available.

Reference Type RESULT
PMID: 20631571 (View on PubMed)

Other Identifiers

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NRA1280017

Identifier Type: -

Identifier Source: secondary_id

ZiSe

Identifier Type: -

Identifier Source: org_study_id

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