Study of the Difference Between Anorexia Nervosa with a History of Psychological Trauma and Class… (NCT04804358) | Clinical Trial Compass
TerminatedNot Applicable
Study of the Difference Between Anorexia Nervosa with a History of Psychological Trauma and Classical Anorexia Nervosa on the Neurocognitive and Neurophysiological Factors
Stopped: The person in charge of the clinical study had to leave the hospital prematurely.
France4 participantsStarted 2021-09-17
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 card…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in high frequency heart variability (HF-HRV) across the exposition test (before, during and after)