Oxytocin and Incitement to Use Olfactory Stimuli in Restrictive Anorexia Nervosa

February 25, 2019 updated by: Fondation Lenval

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: at 3 months
at 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Lenval

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 14-AOI-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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