Neurobehavioral Moderators of Post-traumatic Disease Trajectories

PTSD Clinical Trial

Official title:

Neurobehavioral Moderators of Post-traumatic Disease Trajectories: Prospective MRI Study of Recent Trauma Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03756545
• Other study ID #: 0207-14-TLV
• Secondary ID: R01MH103287
• Status: Completed
• Start date: January 20, 2015
• Est. completion date: March 11, 2020

Study information

• Verified date: March 2020
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The research goal is to uncover the neurocognitive moderators of PTSD trajectories, by documenting clinical symptoms, cognitive functioning, and brain structure and function, one-, six- and fourteen months following a traumatic event, in a large population of survivors at initial high risk for PTSD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: March 11, 2020
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18 - 65 years

• Able to read and comprehend Hebrew

• Arrived in the ER because of one of the following: car accidents, terrorist attacks, work accidents, home accidents, burns, physical assault, large-scale disaster.

Exclusion Criteria:

• Individuals with known claustrophobia

• Individuals with history of substance abuse

• Individuals with current or past psychotic or bipolar I disorder

• Individuals with chronic PTSD at the time of the current trauma

• Individuals on psychotropic medication or recreational drugs in the week that precedes the MRI

• Individuals with hearing problems

• Individuals with head trauma with coma exceeding 30 minutes

• Individuals which can't perform MRI due to safety reasons (e.g. irremovable metals in their body)

Related Conditions & MeSH terms

• PTSD
• Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
Israel	Tel-Aviv Sourasky Medical Center	Tel-Aviv

Sponsors (4)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	National Institute of Mental Health (NIMH), New York University, Texas A&M University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CAPS Total Scores	The Clinician-Administered PTSD Scale, used to assess PTSD diagnostic status and symptom severity. CAPS total symptom severity score is calculated by summing severity scores for all PTSD symptoms. We use both CAPS-V (according to DSM-4) and CAPS-5 (according to DSM-5).	one-, six- and fourteen months following a traumatic event