Posttraumatic Stress DisorderPhase 4NCT00208208
Geodon (Ziprasidone) for Posttraumatic Stress Disorder
A Phase 4 study testing Ziprasidone in people with Posttraumatic Stress Disorder and Post-Traumatic Stress Disorder, run by Creighton University at 1 site in United States.
Trial summary
Atypical antipsychotics have shown promise in the treatment of depression and anxiety, which are prominent symptoms of PTSD. The profile of the atypical antipsychotic, ziprasidone (Geodon), suggests possible anxiolytic and antidepressant properties. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder, Post-Traumatic Stress Disorder, PTSD
- What is being tested?
- Ziprasidone
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2002to Apr 2005
- Phase
- Phase 4
- 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 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men \& women with DSM-IV clinical diagnosis of PTSD who are able to attend weekly clinic appointments
- Age 19-64, not pregnant and either sterile or using a medically acceptable method of birth control
- A willingness and ability to provide competent signed informed consent
- A level of understanding sufficient to perform all tests and examinations required by the protocol (including fluency of spoken English)
Who cannot join
- Any diagnosis of schizophrenia or bipolar I disorder, or active substance dependence
- Unstable general medical condition or serious illness (e.g.. death or hospitalization is anticipated within one year), poor kidney function, liver function (defined as lab values ≥ three times the upper limit of the laboratory normal) and seizure disorders with the exception of childhood seizure disorders.
- Subjects with prior non-response to Geodon for the treatment of PTSD with an adequate trial
- Enrollment in any study drug within the last 30 days. Current pharmacotherapy is permitted, provided that the medication and dose have been stable for the past 90 days.
- Pregnancy or nursing
- Any subject judged clinically to be at serious suicidal risk in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton University Psychiatry and Research Center
Omaha, Nebraska, 68131
About this study
Atypical antipsychotics have shown promise in the treatment of depression and anxiety, which are prominent symptoms of PTSD. The profile of the atypical antipsychotic, ziprasidone (Geodon), suggests possible anxiolytic and antidepressant properties. This research will assess the potential effectiveness of Geodon in civilian men and women who suffer from severe PTSD. Response to ziprasidone or placebo will be measured by Clinician Administered PTSD Scale (CAPS) and Treatment Outcomes PTSD Scale (TOP-8).
Read the detailed description
PTSD is a common disorder with 10% lifetime prevalence among Americans. The major causes of PTSD are sexual assault, accidents, disasters Despite this public health burden, only two drugs, sertraline (Zoloft) and paroxetine (Paxil), are approved by the FDA for the treatment of PTSD. New options for the treatment of PTSD are much needed. Approximately half of patients with PTSD respond to Zoloft and Paxil. Many patients experience psychotic symptoms with PTSD, which may not respond to treatment to Zoloft and Paxil.
Though classified as an anxiety disorder in the DSM-IV, PTSD is accompanied by psychotic symptoms in almost half of patients (Butler et al 1996; Hamner et al 1999, Lindley et al 2000). Also, PTSD has an extensive comorbidity with major depressive disorder (Davis et al 2000). While Geodon is approved by the FDA in the United States for the treatment of psychosis, it has not been evaluated for the treatment of PTSD . A clinical trial of Geodon in PTSD will help delineate the potential antidepressant spectrum of efficacy of Geodon as well as its anxiolytic profile.
- Being tested
- Ziprasidone
- Keywords
- Posttraumatic Stress Disorder, Post-traumatic Stress Disorder, PTSD, Geodon, Ziprasidone
- 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.
ZiprasidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to ziprasidone or placebo (inactive drug) will be measured by Clinician Administered PTSD Scale (CAPS) and Treatment Outcomes PTSD Scale (TOP-8).
Secondary outcomes (1)
A secondary aim of the study is to measure effects on depression and anxiety symptoms in the same persons, using the HAM-A, HAM-D and the CGI. Quality of life will also be assessed using the QOLI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 2002
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Frederick Petty, MD, PhD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208208
- Sponsor's protocol ID
- 2001-0261
- Other IDs
- Grant 2001-0261
- Status last verified
- Apr 2005
- First submitted
- 14 Sep 2005
- Last updated
- 15 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geodon (Ziprasidone) for Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00208208
- Acronym / sponsor ID
- 2001-0261
- Keywords
- Posttraumatic Stress Disorder, Post-traumatic Stress Disorder, PTSD, Geodon, Ziprasidone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Dec 2002
- Study completion
- Apr 2005
- First posted
- 21 Sep 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.
Atypical antipsychotics have shown promise in the treatment of depression and anxiety, which are prominent symptoms of PTSD. The profile of the atypical antipsychotic, ziprasidone (Geodon), suggests possible anxiolytic and antidepressant properties. This research will assess the potential effectiveness of Geodon in civilian men and women who suffer from severe PTSD. Response to ziprasidone or placebo will be measured by Clinician Administered PTSD Scale (CAPS) and Treatment Outcomes PTSD Scale (TOP-8).
Detailed description
PTSD is a common disorder with 10% lifetime prevalence among Americans. The major causes of PTSD are sexual assault, accidents, disasters Despite this public health burden, only two drugs, sertraline (Zoloft) and paroxetine (Paxil), are approved by the FDA for the treatment of PTSD. New options for the treatment of PTSD are much needed. Approximately half of patients with PTSD respond to Zoloft and Paxil. Many patients experience psychotic symptoms with PTSD, which may not respond to treatment to Zoloft and Paxil.
Though classified as an anxiety disorder in the DSM-IV, PTSD is accompanied by psychotic symptoms in almost half of patients (Butler et al 1996; Hamner et al 1999, Lindley et al 2000). Also, PTSD has an extensive comorbidity with major depressive disorder (Davis et al 2000). While Geodon is approved by the FDA in the United States for the treatment of psychosis, it has not been evaluated for the treatment of PTSD . A clinical trial of Geodon in PTSD will help delineate the potential antidepressant spectrum of efficacy of Geodon as well as its anxiolytic profile.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men \& women with DSM-IV clinical diagnosis of PTSD who are able to attend weekly clinic appointments
- Age 19-64, not pregnant and either sterile or using a medically acceptable method of birth control
- A willingness and ability to provide competent signed informed consent
- A level of understanding sufficient to perform all tests and examinations required by the protocol (including fluency of spoken English)
Key exclusion criteria (6 listed)
- Any diagnosis of schizophrenia or bipolar I disorder, or active substance dependence
- Unstable general medical condition or serious illness (e.g.. death or hospitalization is anticipated within one year), poor kidney function, liver function (defined as lab values ≥ three times the upper limit of the laboratory normal) and seizure disorders with the exception of childhood seizure disorders.
- Subjects with prior non-response to Geodon for the treatment of PTSD with an adequate trial
- Enrollment in any study drug within the last 30 days. Current pharmacotherapy is permitted, provided that the medication and dose have been stable for the past 90 days.
- Pregnancy or nursing
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 | Drug | – |
Primary outcome
Response to ziprasidone or placebo (inactive drug) will be measured by Clinician Administered PTSD Scale (CAPS) and Treatment Outcomes PTSD Scale (TOP-8).
1 secondary outcome
A secondary aim of the study is to measure effects on depression and anxiety symptoms in the same persons, using the HAM-A, HAM-D and the CGI. Quality of life will also be assessed using the QOLI.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2006.
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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.
Frederick Petty, MD, PhD principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ziprasidone in people with Posttraumatic Stress Disorder and Post-Traumatic Stress Disorder, run by Creighton University at 1 site in United States.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 15 Sep 2006. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response to ziprasidone or placebo (inactive drug) will be measured by Clinician Administered PTSD Scale (CAPS) and Treatment Outcomes PTSD Scale (TOP-8).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2006; AzTrials last refreshed its copy on 31 Oct 2026.