PTSDNCT00233467
Characterization of the Use of Antipsychotics in Posttraumatic Stress Disorder During the Past Decade
An observational study of PTSD and Posttraumatic Stress Disorder, run by Tuscaloosa Research & Education Advancement Corporation at 1 site in United States.
Trial summary
The main purpose is to show the percentage of patients taking antipsychotics with PTSD by looking at approximately ten year's worth of data from 1994 through 2004. We will also determine the type and dose of antipsychotics the patients received, and to determine how many of those patients had psychotic versus… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- PTSD, Posttraumatic Stress Disorder
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2005to 30 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
Study population: Chart review of Veterans on antipsychotics
Who may be able to join
- Have a diagnosis of PTSD (309.81)
- Male or female patients at least 19 years of age
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Tuscaloosa VA Medical Center
Tuscaloosa, Alabama, 35404
About this study
The main purpose is to show the percentage of patients taking antipsychotics with PTSD by looking at approximately ten year's worth of data from 1994 through 2004. We will also determine the type and dose of antipsychotics the patients received, and to determine how many of those patients had psychotic versus nonpsychotic symptoms. We will be obtaining this data from the VISN 7 Corporate Data Warehouse. We hypothesize that there has been an overall increase in antipsychotic use in patient's with PTSD over the last 10 years.
Read the detailed description
This study is a retrospective chart review of patients, at the Tuscaloosa VA Medical Center, who were, treated with antipsychotics as monotherapy or adjunctive therapy.
The data will be retrieved from a computerized list of patients treated at the TVAMC for PTSD from 1994-2004 Charts will be reviewed by looking at approximately ten year's worth of data. Charts will then be examined to determine what type of antipsychotics patients were prescribed, the dose and duration of the antipsychotics, and the presence or absence of documented psychotic symptoms.
- Conditions
- PTSD, Posttraumatic Stress Disorder
- Keywords
- antipsychotics, PTSD, posttraumatic stress disorder
- 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 posted5 Oct 2005 (estimated)
- Study start1 Sep 2005
- Primary completion30 Sep 2005
- Study completion30 Sep 2005
Why it stopped: Funding expired; no subjects enrolled as this was a retrospective chart review
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuscaloosa Research & Education Advancement Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation
- Investigators
- Rebecca Seamans, PharmD, Principal investigator, Tuscaloosa Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233467
- Sponsor's protocol ID
- TREAC Retro PTSD
- Status last verified
- Sep 2017
- First submitted
- 3 Oct 2005
- Last updated
- 14 Sep 2017
- 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 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Use of Antipsychotics in Posttraumatic Stress Disorder During the Past Decade
- ClinicalTrials.gov ID
- NCT00233467
- Acronym / sponsor ID
- TREAC Retro PTSD
- Conditions
- PTSD, Posttraumatic Stress Disorder
- Keywords
- antipsychotics, PTSD, posttraumatic stress disorder
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding expired; no subjects enrolled as this was a retrospective chart review
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tuscaloosa Research & Education Advancement CorporationUniversity, hospital or other
- Study start
- 1 Sep 2005 (actual)
- Primary completion
- 30 Sep 2005 (actual)
- Study completion
- 30 Sep 2005 (actual)
- First posted
- 5 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 main purpose is to show the percentage of patients taking antipsychotics with PTSD by looking at approximately ten year's worth of data from 1994 through 2004. We will also determine the type and dose of antipsychotics the patients received, and to determine how many of those patients had psychotic versus nonpsychotic symptoms. We will be obtaining this data from the VISN 7 Corporate Data Warehouse. We hypothesize that there has been an overall increase in antipsychotic use in patient's with PTSD over the last 10 years.
Detailed description
This study is a retrospective chart review of patients, at the Tuscaloosa VA Medical Center, who were, treated with antipsychotics as monotherapy or adjunctive therapy.
The data will be retrieved from a computerized list of patients treated at the TVAMC for PTSD from 1994-2004 Charts will be reviewed by looking at approximately ten year's worth of data. Charts will then be examined to determine what type of antipsychotics patients were prescribed, the dose and duration of the antipsychotics, and the presence or absence of documented psychotic symptoms.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chart review of Veterans on antipsychotics
Key inclusion criteria (2 listed)
- Have a diagnosis of PTSD (309.81)
- Male or female patients at least 19 years of age
Key exclusion criteria (1 listed)
- None
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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- 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.
Rebecca Seamans, PharmD 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 Posttraumatic 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 2 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: withdrawn, as of the sponsor's last update on 14 Sep 2017. 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 was withdrawn before enrolling participants, so there are no results.
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 NCT00233467, 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 14 Sep 2017.