Oxytocin and Incitement to Use Olfactory Stimuli in Restrictive Anorexia Nervosa

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

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.

Study Overview

• Status: Completed
• Conditions: Anorexia
• Intervention / Treatment: Other: olfactory workshop; Other: other workshop; Other: No intervention

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06200
    • Fondation Lenval Hôpitaux pediatriques CHU de Nice Fondation Lenval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: olfactory workshop; Influence of sensory therapy on the rate of oxytocin	Other: olfactory workshop; olfactory workshop
Active Comparator: other workshop; Influence of other workshop on the rate of oxytocin	Other: other workshop; other workshop: discussion group, dance and body Expression
Other: control group; Rate of oxytocin of the control group	Other: No intervention; control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Score "Wanting" to olfactory stimuli	at 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Oxytocin serum level	at 3 months
Body mass index	at 3 months
Scores to clinical scales	at 3 months
Scores to hedonicity scale	at 3 months
Scores to "liking"-"wanting" tests	at 3 months

Collaborators and Investigators

• Sponsor: Fondation Lenval
• Investigators: Principal Investigator: Florence ASKENAZY, PU-PH, Hôpitaux pediatriques CHU de Nice Fondation Lenval

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2015
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: December 26, 2014
• First Submitted That Met QC Criteria: January 6, 2015
• First Posted (Estimate): January 7, 2015

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: 14-AOI-06