Oxytocin and Incitement to Use Olfactory Stimuli in Restrictive Anorexia Nervosa

Anorexia Clinical Trial

Official title:

Pilot Study: a Comparative Study Between Serum Levels of Oxytocin and Incitement to Use Olfactory Stimuli in Restrictive Anorexia Nervosa in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02333500
• Other study ID #: 14-AOI-06
• Status: Completed
• Phase: N/A
• Start date: February 11, 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2018
• Source: Fondation Lenval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Other:
• olfactory workshop
olfactory workshop
• other workshop
other workshop: discussion group, dance and body Expression
• No intervention
control group

Locations

Country	Name	City	State
France	Fondation Lenval Hôpitaux pediatriques CHU de Nice Fondation Lenval	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Lenval

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score "Wanting" to olfactory stimuli		at 3 months
Secondary	Oxytocin serum level		at 3 months
Secondary	Body mass index		at 3 months
Secondary	Scores to clinical scales		at 3 months
Secondary	Scores to hedonicity scale		at 3 months
Secondary	Scores to "liking"-"wanting" tests		at 3 months