Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-02-27 @ 2:20 PM
Study NCT ID:
NCT03343028
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2016-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarker Establishment for Superior Treatment of PTSD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011613', 'term': 'Psychotherapy'}], 'ancestors': [{'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-10', 'studyFirstSubmitDate': '2016-11-04', 'studyFirstSubmitQcDate': '2017-11-10', 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Understanding the brain network function-neuroimaging and behavioral with Clinician-Administered PTSD Scale for DSM-5', 'timeFrame': 'Approximately 3 months', 'description': 'We will be using CAPS 5'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['veterans', 'post traumatic stress disorder', 'depression'], 'conditions': ['PTSD']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of PTSD by VA clinicians and acceptance into PE or CPT treatment as part of the PCT\n* Veterans of any era\n\nExclusion Criteria:\n\n* MRI safety contraindications\n* Active, uncontrolled medical illness\n* Acute suicidality\n* Current substance dependence\n* Current use of thyroid medication or active hyper/hypothyroidism\n* Neurological disorder affecting the CNS Seg stroke, epilepsy, tumorW or penetrating head injury\n* Use of PRN within 48 hours of the MRI/EEG'}, 'identificationModule': {'nctId': 'NCT03343028', 'briefTitle': 'Biomarker Establishment for Superior Treatment of PTSD', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Biomarker Establishment for Superior Treatment of PTSD', 'orgStudyIdInfo': {'id': '39006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Psychotherapy', 'description': '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.', 'interventionNames': ['Other: Psychotherapy']}, {'label': 'Healthy Controls', 'description': '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.'}], 'interventions': [{'name': 'Psychotherapy', 'type': 'OTHER', 'otherNames': ['Cognitive Processing Therapy', 'Prolonged Exposure'], 'armGroupLabels': ['Psychotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'VA Palo Alto Health Care System (VAPAHCS)', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '87108', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'New Mexico VA Health Care System', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Alan Schatzberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'New Mexico VA Healthcare System', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Kenneth T. Norris, Jr. Professor of Psychiatry and Behavioral Sciences', 'investigatorFullName': 'Alan Schatzberg', 'investigatorAffiliation': 'Stanford University'}}}}