PTSDNCT00230893
Characterization of the Use of Antipsychotics in PTSD During the Past Seven Years
An observational study of PTSD and Post-Traumatic Stress Disorder, run by Tuscaloosa Research & Education Advancement Corporation at 1 site in United States.
Trial summary
The primary objective is to examine the percentage of patients with PTSD who were prescribed an antipsychotic over the past seven years in the VA Network 7 (AL, GA, SC) and compare the percentage on an annual basis. We will also determine the type and dose of antipsychotics received. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- PTSD, Post-Traumatic Stress Disorder
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Sep 2005
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, any race or ethnic origin at least 19 years of age.
- Patients with a diagnosis of PTSD
- Treated with an antipsychotic as a monotherapy or adjunctive therapy
- Patient must have been seen at a VA medical center or clinic within VISN 7 during the study period.
Who cannot join
- Patients not diagnosed with PTSD
- Not treated with an antipsychotic as a monotherapy or adjunctive therapy
- Patients outside of Network 7
- Patients with a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Tuscaloosa VA Medical Center
Tuscaloosa, Alabama, 35404
About this study
The primary objective is to examine the percentage of patients with PTSD who were prescribed an antipsychotic over the past seven years in the VA Network 7 (AL, GA, SC) and compare the percentage on an annual basis. We will also determine the type and dose of antipsychotics received. We hypothesize that there has been a significant increase in antipsychotic use, especially atypical antipsychotics, prescribed for patients with PTSD over the last 7 years
Read the detailed description
This study is a retrospective electronic review of the VISN 7 Data Warehouse to determine what have been the emerging trends in prescriptions of atypical antipsychotic medications over the past seven years for the treatment of posttraumatic stress disorder (PTSD) in the VA
This study is a retrospective electronic review of patients of the VISN 7 Data Warehouse of patients with a diagnosis of PTSD treated with antipsychotics as monotherapy or adjunctive therapy at a VA Medical Center or VA clinic in VISN 7 (GA, SC, and AL). The data will be retrieved from a computerized list of patients treated in VA VISN 7 for PTSD from 1998-2005 and cross-referenced with the electronic pharmacy file for having received a prescription of an antipsychotic medication. No personal identifiers will be collected. The data will then be examined to determine what type of antipsychotics were prescribed and the dose and duration of the antipsychotics. In addition, demographics and clinical characteristics available through the Data Warehouse will be collected.
- Conditions
- PTSD, Post-Traumatic Stress Disorder
- Keywords
- Antipsychotics, PTSD, Post Traumatic Stress Disorder, monotherapy, adjunct therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2005 (estimated)
- Study startJul 2005
- Study completionSep 2005
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 PTSDStudies 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
- Observational
- Observational model
- Defined population
- Time perspective
- Retrospective
- Enrolment
- 99 participants
Sponsor and investigators
- Lead sponsor
- Tuscaloosa Research & Education Advancement Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, LP
- Investigators
- Lori L. Davis, MD, Principal investigator, Tuscaloosa Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230893
- Sponsor's protocol ID
- TREAC - PTSD Retrospective
- Other IDs
- TREAC - PTSD Retrospective
- Status last verified
- Sep 2006
- First submitted
- 29 Sep 2005
- Last updated
- 21 Sep 2006
- Results posted
- No
Publications
Kozaric-Kovacic D, Pivac N, Muck-Seler D, Rothbaum BO. Risperidone in psychotic combat-related posttraumatic stress disorder: an open trial. J Clin Psychiatry. 2005 Jul;66(7):922-7. doi: 10.4088/jcp.v66n0716.
PubMed 16013909
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Use of Antipsychotics in PTSD During the Past Seven Years
- ClinicalTrials.gov ID
- NCT00230893
- Acronym / sponsor ID
- TREAC - PTSD Retrospective
- Conditions
- PTSD, Post-Traumatic Stress Disorder
- Keywords
- Antipsychotics, PTSD, Post Traumatic Stress Disorder, monotherapy, adjunct therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants
- Lead sponsor
- Tuscaloosa Research & Education Advancement CorporationUniversity, hospital or other
- Collaborators
- Janssen, LP
- Study start
- Jul 2005
- Study completion
- Sep 2005
- First posted
- 3 Oct 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.
The primary objective is to examine the percentage of patients with PTSD who were prescribed an antipsychotic over the past seven years in the VA Network 7 (AL, GA, SC) and compare the percentage on an annual basis. We will also determine the type and dose of antipsychotics received. We hypothesize that there has been a significant increase in antipsychotic use, especially atypical antipsychotics, prescribed for patients with PTSD over the last 7 years
Detailed description
This study is a retrospective electronic review of the VISN 7 Data Warehouse to determine what have been the emerging trends in prescriptions of atypical antipsychotic medications over the past seven years for the treatment of posttraumatic stress disorder (PTSD) in the VA
This study is a retrospective electronic review of patients of the VISN 7 Data Warehouse of patients with a diagnosis of PTSD treated with antipsychotics as monotherapy or adjunctive therapy at a VA Medical Center or VA clinic in VISN 7 (GA, SC, and AL). The data will be retrieved from a computerized list of patients treated in VA VISN 7 for PTSD from 1998-2005 and cross-referenced with the electronic pharmacy file for having received a prescription of an antipsychotic medication. No personal identifiers will be collected. The data will then be examined to determine what type of antipsychotics were prescribed and the dose and duration of the antipsychotics. In addition, demographics and clinical characteristics available through the Data Warehouse will be collected.
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients, any race or ethnic origin at least 19 years of age.
- Patients with a diagnosis of PTSD
- Treated with an antipsychotic as a monotherapy or adjunctive therapy
- Patient must have been seen at a VA medical center or clinic within VISN 7 during the study period.
Key exclusion criteria (4 listed)
- Patients not diagnosed with PTSD
- Not treated with an antipsychotic as a monotherapy or adjunctive therapy
- Patients outside of Network 7
- Patients with a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 21 Sep 2006.
- Background: PubMed 16013909Kozaric-Kovacic D, Pivac N, Muck-Seler D, Rothbaum BO. Risperidone in psychotic combat-related posttraumatic stress disorder: an open trial. J Clin Psychiatry. 2005 Jul;66(7):922-7. doi: 10.4088/jcp.v66n0716.
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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.
Lori L. Davis, MD principal investigator
Tuscaloosa Veterans Affairs Medical Center
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 PTSD and Post-Traumatic Stress Disorder, run by Tuscaloosa Research & Education Advancement Corporation 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 4 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 21 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00230893, 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 21 Sep 2006.