PTSDNCT03343028
Biomarker Establishment for Superior Treatment of PTSD
An observational study of PTSD, run by Stanford University at 2 sites in United States.
Trial summary
The purpose of Biomarker Establishment for Superior Treatment of PTSD is to accelerate research on the discovery of biological, neurological and neuroimaging markers for Post- Traumatic Stress Disorder (PTSD). The investigators hope to validate and extend the network efficiency and verbal memory biomarker for PTSD. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- PTSD
- What is being tested?
- Psychotherapy
- How many people
- 292 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2016to 30 Sep 2019
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: We will assess and acquire data on these Veterans across the course of the project prior to and after receiving Prolonged Exposure (PE) or Cognitive Processing Theory (CPT) treatment at VA Palo Alto (VAPAHCS) and the Albuquerque VA.
Who may be able to join
- Diagnosis of PTSD by VA clinicians and acceptance into PE or CPT treatment as part of the PCT
- Veterans of any era
Who cannot join
- MRI safety contraindications
- Active, uncontrolled medical illness
- Acute suicidality
- Current substance dependence
- Current use of thyroid medication or active hyper/hypothyroidism
- Neurological disorder affecting the CNS Seg stroke, epilepsy, tumorW or penetrating head injury
- Use of PRN within 48 hours of the MRI/EEG
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New Mexico VA Health Care System
Albuquerque, New Mexico, 87108
VA Palo Alto Health Care System (VAPAHCS)
Palo Alto, California, 94304
About this study
The purpose of Biomarker Establishment for Superior Treatment of PTSD is to accelerate research on the discovery of biological, neurological and neuroimaging markers for Post- Traumatic Stress Disorder (PTSD). The investigators hope to validate and extend the network efficiency and verbal memory biomarker for PTSD. The investigators hope to learn whether there are pretreatment biological factors that can predict response to therapy. They want to do this by understanding the brain network function, relating EEG to functional magnetic resonance imaging, and application of network analysis tool.
- Conditions
- PTSD
- Being tested
- Psychotherapy
- Keywords
- veterans, post traumatic stress disorder, depression
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyOther
Also called Cognitive Processing Therapy, Prolonged Exposure
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy | The investigators will assess and acquire data on these Veterans across the course of the project prior to and after receiving Prolonged Exposure (PE) or Cognitive Processing Theory (CPT) treatment at VA Palo Alto (VAPAHCS) and the Albuquerque VA. They will acquire fMRI, behavioral, EEG, TMS/EEG, and saliva at baseline on these Veterans and again 3 months after treatment to assess prediction and durability of the clinical and brain/behavioral metrics. All study assessments will take place at Stanford University/VAPAHCS. Subjects will be recruited through VAPAHCS and Albuquerque VA. Subjects will complete a clinical assessment including: neuroimaging, self-report questionnaires completed via computer or paper-and-pencil, cognitive testing, saliva, and TMS and EEG assessments. Receives: Other: Psychotherapy | |
| Healthy Controls | The investigators will assess and acquire data on these Veterans who do not have history of PTSD and have no history of any Axis I psychiatric disorder, are taking psychotropic medication, or use illicit drugs. They will acquire fMRI, behavioral, EEG, TMS/EEG, and saliva once. All study assessments will take place at Stanford University. Subjects will be recruited through public flying, online ads and VAPAHCS. Subjects will complete a clinical assessment including: neuroimaging, self-report questionnaires completed via computer or paper-and-pencil, cognitive testing, saliva, and TMS and EEG assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding the brain network function-neuroimaging and behavioral with Clinician-Administered PTSD Scale for DSM-5
We will be using CAPS 5
Measured: Approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study startSep 2016
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- New Mexico VA Healthcare System
- Responsible party
- Principal investigator, Alan Schatzberg, Stanford University
- Investigators
- Alan Schatzberg, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343028
- Sponsor's protocol ID
- 39006
- Status last verified
- Feb 2020
- First submitted
- 4 Nov 2016
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Establishment for Superior Treatment of PTSD
- ClinicalTrials.gov ID
- NCT03343028
- Acronym / sponsor ID
- 39006
- Conditions
- PTSD
- Keywords
- veterans, post traumatic stress disorder, depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- New Mexico VA Healthcare System
- Study start
- Sep 2016
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 17 Nov 2017 (actual)
- 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 purpose of Biomarker Establishment for Superior Treatment of PTSD is to accelerate research on the discovery of biological, neurological and neuroimaging markers for Post- Traumatic Stress Disorder (PTSD). The investigators hope to validate and extend the network efficiency and verbal memory biomarker for PTSD. The investigators hope to learn whether there are pretreatment biological factors that can predict response to therapy. They want to do this by understanding the brain network function, relating EEG to functional magnetic resonance imaging, and application of network analysis tool.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy | – | Other: PsychotherapyThe investigators will assess and acquire data on these Veterans across the course of the project prior to and after receiving Prolonged Exposure (PE) or Cognitive Processing Theory (CPT) treatment at VA Palo Alto (VAPAHCS) and the Albuquerque VA. They will acquire fMRI, behavioral, EEG, TMS/EEG, and saliva at baseline on these Veterans and again 3 months after treatment to assess prediction and durability of the clinical and brain/behavioral metrics. All study assessments will take place at Stanford University/VAPAHCS. Subjects will be recruited through VAPAHCS and Albuquerque VA. Subjects will complete a clinical assessment including: neuroimaging, self-report questionnaires completed via computer or paper-and-pencil, cognitive testing, saliva, and TMS and EEG assessments. |
| Healthy Controls | – | –The investigators will assess and acquire data on these Veterans who do not have history of PTSD and have no history of any Axis I psychiatric disorder, are taking psychotropic medication, or use illicit drugs. They will acquire fMRI, behavioral, EEG, TMS/EEG, and saliva once. All study assessments will take place at Stanford University. Subjects will be recruited through public flying, online ads and VAPAHCS. Subjects will complete a clinical assessment including: neuroimaging, self-report questionnaires completed via computer or paper-and-pencil, cognitive testing, saliva, and TMS and EEG assessments. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- We will assess and acquire data on these Veterans across the course of the project prior to and after receiving Prolonged Exposure (PE) or Cognitive Processing Theory (CPT) treatment at VA Palo Alto (VAPAHCS) and the Albuquerque VA.
Key inclusion criteria (2 listed)
- Diagnosis of PTSD by VA clinicians and acceptance into PE or CPT treatment as part of the PCT
- Veterans of any era
Key exclusion criteria (7 listed)
- MRI safety contraindications
- Active, uncontrolled medical illness
- Acute suicidality
- Current substance dependence
- Current use of thyroid medication or active hyper/hypothyroidism
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 |
|---|---|---|
| PsychotherapyAlso: Cognitive Processing Therapy, Prolonged Exposure | Other | Psychotherapy |
Primary outcome
Understanding the brain network function-neuroimaging and behavioral with Clinician-Administered PTSD Scale for DSM-5
Time frame: Approximately 3 months
We will be using CAPS 5
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 12 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Alan Schatzberg, MD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD, run by Stanford University at 2 sites 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 7 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 12 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 2 sites 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.
What does the primary outcome measure?
Understanding the brain network function-neuroimaging and behavioral with Clinician-Administered PTSD Scale for DSM-5 (time frame: Approximately 3 months). 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 12 Feb 2020; AzTrials last refreshed its copy on 7 Nov 2026.