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Oxytocin and Incitement to Use Olfactory Stimuli in Restrictive Anorexia Nervosa

Primary Purpose

Anorexia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
olfactory workshop
other workshop
No intervention
Sponsored by
Fondation Lenval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Anorexia

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Fondation Lenval Hôpitaux pediatriques CHU de Nice Fondation Lenval

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

olfactory workshop

other workshop

control group

Arm Description

Influence of sensory therapy on the rate of oxytocin

Influence of other workshop on the rate of oxytocin

Rate of oxytocin of the control group

Outcomes

Primary Outcome Measures

Score "Wanting" to olfactory stimuli

Secondary Outcome Measures

Oxytocin serum level
Body mass index
Scores to clinical scales
Scores to hedonicity scale
Scores to "liking"-"wanting" tests

Full Information

First Posted
December 26, 2014
Last Updated
February 25, 2019
Sponsor
Fondation Lenval
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1. Study Identification

Unique Protocol Identification Number
NCT02333500
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 11, 2015 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Lenval

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
olfactory workshop
Arm Type
Experimental
Arm Description
Influence of sensory therapy on the rate of oxytocin
Arm Title
other workshop
Arm Type
Active Comparator
Arm Description
Influence of other workshop on the rate of oxytocin
Arm Title
control group
Arm Type
Other
Arm Description
Rate of oxytocin of the control group
Intervention Type
Other
Intervention Name(s)
olfactory workshop
Intervention Description
olfactory workshop
Intervention Type
Other
Intervention Name(s)
other workshop
Intervention Description
other workshop: discussion group, dance and body Expression
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
control group
Primary Outcome Measure Information:
Title
Score "Wanting" to olfactory stimuli
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
Oxytocin serum level
Time Frame
at 3 months
Title
Body mass index
Time Frame
at 3 months
Title
Scores to clinical scales
Time Frame
at 3 months
Title
Scores to hedonicity scale
Time Frame
at 3 months
Title
Scores to "liking"-"wanting" tests
Time Frame
at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence ASKENAZY, PU-PH
Organizational Affiliation
Hôpitaux pediatriques CHU de Nice Fondation Lenval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation Lenval Hôpitaux pediatriques CHU de Nice Fondation Lenval
City
Nice
ZIP/Postal Code
06200
Country
France

12. IPD Sharing Statement

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Oxytocin and Incitement to Use Olfactory Stimuli in Restrictive Anorexia Nervosa

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