Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT04804358
Status:
TERMINATED
Last Update Posted:
2025-01-10
First Post:
2021-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Difference Between Anorexia Nervosa with a History of Psychological Trauma and Classical Anorexia Nervosa on the Neurocognitive and Neurophysiological Factors
Sponsor:
University Hospital, Montpellier
Organization:
Study Overview
Official Title:
Study of the Difference Between Anorexia Nervosa with a History (s) of Psychological Trauma (AM-T) and Classical Anorexia Nervosa (AM-C) on the Neurocognitive and Neurophysiological Factors
Status:
TERMINATED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The person in charge of the clinical study had to leave the hospital prematurely.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATAC
Brief Summary:
Recent studies suggest that patients with an history of trauma may represent a specific subtype of anorexia nervosa (AM) underlined by specific neurobiological and psychopathological mechanisms. Thus, AM-T subjects would manifest cognitive (specific difficulties in executive functions), emotional (emotional disruption, impulsivity, etc.) and neurobiological (secretion of kynurenine and neurokinins in the face of stress) caracteristics different from those of AM subjects.
Detailed Description:
We will recruit a total of 100 patients with a diagnosis of anorexia nervosa in the university hospital of Montpellier : 50 patients with an history of psychological trauma and 50 patients without any history of psychological trauma
Participation consists of a half-day visit. Patients will perform clinical and neuropsychological assessments and an exposition test. During this test, participants will be exposed, for 7 minutes, to neutral, positive or negative emotional photos. Heart rate variability will be determined through a Biopac MP160 before, during and after this event. Saliva samples to measure kynurenin, tryptophan, substance P and neurokinin-1 will be collected before and directly after the test.
Participation consists of a half-day visit. Patients will perform clinical and neuropsychological assessments and an exposition test. During this test, participants will be exposed, for 7 minutes, to neutral, positive or negative emotional photos. Heart rate variability will be determined through a Biopac MP160 before, during and after this event. Saliva samples to measure kynurenin, tryptophan, substance P and neurokinin-1 will be collected before and directly after the test.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: