Clinical trial NCT02333500: Oxytocin and Incitement to Use Olfactory Stimuli in Restrictive Anorexia Nervosa
Official title: Pilot Study: a Comparative Study Between Serum Levels of Oxytocin and Incitement to Use Olfactory Stimuli in Restrictive Anorexia Nervosa in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 30
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This prospective pilot study will compare adolescents with restrictive anorexia nervosa who participated for 3 months at olfactory workshops, patients who did not, and healthy patients.The groups will be evaluated before the workshops and after three months, with the wanting score after olfactory stimuli and with serum oxytocin level.

Detailed description: The restrictive anorexia nervosa (AN) in adolescents is an eating disorder with decreased desire to eat (wanting) following olfactory stimulation. Oxytocin is an hormone involved in the neuromodulation of eating behavior, but also involved in olfactory perception in schizophrenia patients, and in social cognition in patients with autism. Its plasma level was found low in anorexic patients compared to control subjects.

Because of the similarity in disorders of social cognition between these three diseases, we assume that the desire to eat evoked by olfactory perception varies with the plasma oxytocin levels.

With a prospective pilot study we will compare patients with AN who participated for 3 months at olfactory workshops, AN patients who did not, and healthy patients.

The groups will be evaluated before the workshops and after three months, with the wanting score after olfactory stimuli and with serum oxytocin level.

One application of this study will be the use of ocytocyne nasal spray to increase the eating desire and to allow weight regain

Eligibility criteria: Inclusion Criteria:

* Medical-Review
* Female or male -Sexe,
* 11 to 18 years
* Anorexia nervosa diagnosed according to the criteria DSM V
* Outpatient care or hospitalization
* Be able to answer the clinicals evaluations questionnaires
* Affiliated to social security
* Consentement of the legal representative and the patient

Exclusion Criteria:

* Somatic comorbidity associated with diabetes, celiac disease, brain tumor
* Intolerance odors, predisposed to develop asthma and / or respiratory allergies Pathologie chronic rhino-sinus
* Hyposmiques or anosmic
* Patients not of an inclusion criteria

Primary outcomes:
measure: Score "Wanting" to olfactory stimuli
timeFrame: at 3 months
Secondary outcomes:
measure: Oxytocin serum level
timeFrame: at 3 months
measure: Body mass index
timeFrame: at 3 months
measure: Scores to clinical scales
timeFrame: at 3 months
measure: Scores to hedonicity scale
timeFrame: at 3 months
measure: Scores to "liking"-"wanting" tests
timeFrame: at 3 months
Other outcomes:
Locations:
city: Nice
country: France
facility: Fondation Lenval Hôpitaux pediatriques CHU de Nice Fondation Lenval
Study officials:
affiliation: Hôpitaux pediatriques CHU de Nice Fondation Lenval
name: Florence ASKENAZY, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: