[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02757339":3,"trial-entities:NCT02757339":80,"trial-summary:NCT02757339":84},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":32,"secondary_outcomes":37,"sex":38,"minimum_age":39,"maximum_age":40,"healthy_volunteers":41,"eligibility_criteria":42,"std_ages":60,"locations":63,"central_contacts":73,"overall_officials":74,"references":78,"see_also_links":79},"NCT02757339","2014P001429","Evaluating the Neurobiological Basis of Traumatic Dissociation in Women With Histories of Abuse and Neglect","Evaluating the Neurobiological Basis of Traumatic Dissociation in a Cross-Diagnostic Sample of Women With Histories of Childhood Abuse and Neglect","ENROLLING_BY_INVITATION","2027-06","2026-06","2026-06-25","2015-06","Mclean Hospital","OTHER",false,"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.","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.\n\nTo 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.\n\nThis study will also include a follow up visit that includes neuroimaging and genetic assessments.",[19,20],"Posttraumatic Stress Disorders","Dissociative Identity Disorder",[22,23,24],"neurobiology","PTSD","DID","OBSERVATIONAL",null,[],{"count":29,"type":30},200,"ESTIMATED",[],[33],{"measure":34,"description":35,"timeFrame":36},"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",[],"FEMALE","18 Years","89 Years",true,{"inclusion":43,"exclusion":48,"raw_text":59},[44,45,46,47],"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",[49,50,51,52,53,54,55,56,57,58],"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)","Inclusion Criteria:\n\n* Female\n* Clinical diagnosis of PTSD or DID and history of childhood abuse, or healthy controls\n* Age between 18 and 89\n* Legal and mental competency of the patient\n\nExclusion Criteria:\n\n* Male\n* Under 18 or over 89\n* Legal or mental incompetence\n* Delirium secondary to medical illness\n* PTSD or DID due to general medical or neurological illness\n* History of neurological conditions that may cause significant psychiatric symptomatology (e.g., dementia)\n* Any contraindication to MR scans, including claustrophobia, pregnancy, metal implants, etc.\n* Current alcohol or substance dependence or abuse (within the last month)\n* A history of schizophrenia or other psychotic disorder\n* History of head injury or loss of consciousness for longer than 5 min (including concussion)",[61,62],"ADULT","OLDER_ADULT",[64],{"facility":65,"city":66,"state":67,"zip":68,"country":69,"geoPoint":70},"McLean Hospital","Belmont","Massachusetts","02478","United States",{"lat":71,"lon":72},42.39593,-71.17867,[],[75],{"name":76,"affiliation":13,"role":77},"Milissa L Kaufman, M.D.\u002FPh.D","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":81,"biomarkers":83},[20,82],"Post-Traumatic Stress Disorder",[],{"nct_id":4,"found":15,"summary":26,"prompt_version":26}]