Post-traumatic Stress DisorderNCT00248261
Ziprasidone and Sertraline in PTSD
An observational study of Post-traumatic Stress Disorder, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- ziprasidone, sertraline
- How many people
- 7 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2005to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PTSD patients
Who may be able to join
- Clinical diagnosis of Post-Traumatic Stress Disorder
Who cannot join
- Lifetime psychotic disorders, current substance dependency, gravidity, lactation, tartrazine hypersensitivity, contraindication against sertraline or ziprasidone
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- ziprasidone, sertraline
- Keywords
- ziprasidone, sertraline, PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ziprasidone, sertralineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Traumatic Diagnostic Scale (PDS)
Measured: 56 days
Secondary outcomes (1)
Beck Depression Inventory (BDI)
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionAug 2009
- Study completionJun 2010
Why it stopped: High rate of early drop-outs
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael B Kellner, MD, PhD, Principal investigator, UKE, Dep. of Pschiatry and Psychotherapy, Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248261
- Sponsor's protocol ID
- ZiSe
- Other IDs
- NRA1280017
- Status last verified
- Feb 2020
- First submitted
- 2 Nov 2005
- Last updated
- 25 Feb 2020
- Results posted
- No
Publications
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.
PubMed 20631571
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00248261
- Acronym / sponsor ID
- ZiSe
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- ziprasidone, sertraline, PTSD
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: High rate of early drop-outs
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 3 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PTSD patients
Key inclusion criteria (1 listed)
- Clinical diagnosis of Post-Traumatic Stress Disorder
Key exclusion criteria (1 listed)
- Lifetime psychotic disorders, current substance dependency, gravidity, lactation, tartrazine hypersensitivity, contraindication against sertraline or ziprasidone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ziprasidone, sertraline | Drug | – |
Primary outcome
Post-Traumatic Diagnostic Scale (PDS)
Time frame: 56 days
1 secondary outcome
Beck Depression Inventory (BDI)
Time frame: 56 days
Results and safety
The study was stopped early (reason given: High rate of early drop-outs). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Results publication: PubMed 20631571Kellner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B Kellner, MD, PhD principal investigator
UKE, Dep. of Pschiatry and Psychotherapy, Hamburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-traumatic Stress Disorder, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: High rate of early drop-outs). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Traumatic Diagnostic Scale (PDS) (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00248261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.