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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02757339
Other study ID # 2014P001429
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 2015
Est. completion date June 2024

Study information

Verified date October 2023
Source Mclean Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to evaluate the neurobiological basis of traumatic dissociation in a cross-diagnostic sample of women who have histories of childhood abuse and neglect.


Description:

Dissociative symptoms commonly are associated with exposure to traumatic stress. Preliminary evidence from functional magnetic resonance imaging-based analysis (fMRI) of neural activation during dissociative symptom provocation in patients with PTSD or DID has implicated certain key structures involved in the generation of dissociative symptoms. Given the presumed region-to-region neural interplay implicit within this model, the investigators believe the use of intrinsic functional connectivity MRI (fcMRI) represents a valuable next line of investigation into the neurobiology of traumatic dissociation. The investigators also believe that a genetic approach holds promise as another converging line of inquiry into our understanding of traumatic dissociation. To evaluate the neurobiological basis of traumatic dissociation, this study will recruit patients with PTSD or DID, and recruit matched controls to identify neurobiological correlates of traumatic dissociation.The study will compare the phenomenology of traumatic dissociation in patients with different PTSD subtypes and DID using standardized measures to look at the neurological and genetic correlates. This study will also include a follow up visit that includes neuroimaging and genetic assessments.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 200
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria: - Female - Clinical diagnosis of PTSD or DID and history of childhood abuse, or healthy controls - Age between 18 and 89 - Legal and mental competency of the patient Exclusion Criteria: - Male - Under 18 or over 89 - Legal or mental incompetence - Delirium secondary to medical illness - PTSD or DID due to general medical or neurological illness - History of neurological conditions that may cause significant psychiatric symptomatology (e.g., dementia) - Any contraindication to MR scans, including claustrophobia, pregnancy, metal implants, etc. - Current alcohol or substance dependence or abuse (within the last month) - A history of schizophrenia or other psychotic disorder - History of head injury or loss of consciousness for longer than 5 min (including concussion)

Study Design


Locations

Country Name City State
United States McLean Hospital Belmont Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline correlates of traumatic dissociation in Functional Magnetic Resonance Imaging at 36 to 56 weeks Study participation will involve a baseline 60 minute cognitive assessment and a 60 minute Magnetic Resonance Imaging (MRI) at the 3 Tesla magnet in the McLean Hospital Imaging Center focusing on attention, emotion regulation, and symptoms of depersonalization. The first time point is baseline.The second time point will be 36-56 weeks after the baseline 60 minute Magnetic Resonance Imaging (MRI) scan at the 3 Tesla magnet in the McLean Hospital Imaging Center. Baseline and 36 to 56 weeks after baseline
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