Clinical trial NCT04804358: Study of the Difference Between Anorexia Nervosa with a History of Psychological Trauma and Classical Anorexia Nervosa on the Neurocognitive and Neurophysiological Factors
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anorexia Nervosa
Keywords: anorexia nervosa
Psychological Trauma
Heart Rate Variability
Kynurenine
Substance P
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion criteria common to the 2 groups AM-T and AM-C :

* Women Patient
* Present a diagnosis of anorexia nervosa according to the DSM-5 criteria
* Between 18 and 65 years old
* Present a BMI\> 14
* Do not present a sight problem or be corrected appropriately by wearing glasses or contact lenses.
* Be affiliated to a social security scheme, or beneficiary of such a scheme
* Be able to understand the nature, purpose and methodology of the study

Inclusion criteria specific to patients in the AM-T group:

- To have answered at least one of the grayed out items of the LEC-5, that is to say to have answered "it happened to me" to at least one of the items 1 to 13 or to item 16 "and / or having answered" I witnessed it "to at least one of items 14 and 15.

Inclusion criteria specific to patients in the AM-C group:

- Not having answered "it happened to me" or "I witnessed it" to one of the items of LEC-5

Exclusion Criteria:

* Present a severe unstable mental pathology in the opinion of the investigator
* Present active suicidal ideation
* Have consumed psychoactive substances in the last 24 hours before the assessment
* Present a severe major depressive episode incompatible with the assessment, in the opinion of the investigator.
* Present in the opinion of the investigator an unstable somatic state (eg severe metabolic disorder making it impossible or likely to impair the reliability of neuropsychological and cardiac evaluations).
* Take a drug treatment acting on the cardiovascular system
* Refusal of the patient
* Be protected by law (tutorship or curatorship).
* To be deprived of liberty by administrative decision.

Primary outcomes:
measure: Changes in high frequency heart variability (HF-HRV) across the exposition test (before, during and after)
timeFrame: inclusion visit
Secondary outcomes:
measure: Changes in low frequency heart variability (LF-HRV) across the exposition test (before, during and after)
timeFrame: inclusion visit
measure: Changes in very low frequency heart variability (VLF-HRV) across the exposition test (before, during and after)
timeFrame: inclusion visit
measure: Changes in the highest peak of the high frequency (HFhz) across the exposition test (before, during and after)
timeFrame: inclusion visit
measure: Changes in the interval between R peaks (R-R across the exposition test (before, during and after)
timeFrame: inclusion visit
measure: Changes in the R-R interval standard difference (STD-RR) across the exposition test (before, during and after)
timeFrame: inclusion visit
measure: Changes in the root mean successive squared differences of the R-R interval (RMSSD). across the exposition test (before, during and after)
timeFrame: inclusion visit
measure: Score to the Difficulties in Emotion Regulation Scale
timeFrame: inclusion visit
measure: Score to the Beck depression inventory II
timeFrame: inclusion visit
measure: Score to the Eating Disorder Questionnaire
timeFrame: inclusion visit
measure: Score to the Eating Disorder Inventory
timeFrame: inclusion visit
measure: Score to the Childhood trauma questionnaire
timeFrame: inclusion visit
measure: Score to the PTSD Checklist for DSM-5
timeFrame: inclusion visit
measure: Score to the Wisconson Card Sorting Test
timeFrame: inclusion visit
measure: Score to the Stroop Test
timeFrame: inclusion visit
measure: Score to the Delay Discounting Test
timeFrame: inclusion visit
measure: Score to the Trail Making Test
timeFrame: inclusion visit
measure: Changes in salivary tryptophan
timeFrame: inclusion visit
measure: Changes in salivary kynurenine
timeFrame: inclusion visit
measure: Changes in salivary P substance
timeFrame: inclusion visit
measure: Changes in salivary neurokinin-1
timeFrame: inclusion visit
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital, Montpellier
Study officials:
References: