NCT00248261

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

3.8 years

First QC Date

November 2, 2005

Last Update Submit

February 22, 2020

Conditions

Post-traumatic Stress Disorder

Keywords

ziprasidone, sertraline, PTSD

Outcome Measures

Primary Outcomes (1)

  • Post-Traumatic Diagnostic Scale (PDS)

    56 days

Secondary Outcomes (1)

  • Beck Depression Inventory (BDI)

    56 days

Interventions

ziprasidone, sertralineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

PTSD patients

You may qualify if:

  • Clinical diagnosis of Post-Traumatic Stress Disorder

You may not qualify if:

  • Lifetime psychotic disorders, current substance dependency, gravidity, lactation, tartrazine hypersensitivity, contraindication against sertraline or ziprasidone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UKE, Dept. of Psychiatry and Psychotherapy

Hamburg, 2ß246, Germany

Location

Related Publications (1)

  • 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.

    PMID: 20631571RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

ziprasidoneSertraline

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Michael B Kellner, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2005

First Posted

November 3, 2005

Study Start

November 1, 2005

Primary Completion

August 1, 2009

Study Completion

June 1, 2010

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations

DE(1)