Oxytocin and Incitement to Use Olfactory Stimuli in Restrictive Anorexia Nervosa

NCT ID: NCT02333500

Last Updated: 2019-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-11

Study Completion Date

2018-12-31

Brief Summary

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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

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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

Conditions

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Anorexia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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olfactory workshop

Influence of sensory therapy on the rate of oxytocin

Group Type EXPERIMENTAL

olfactory workshop

Intervention Type OTHER

olfactory workshop

other workshop

Influence of other workshop on the rate of oxytocin

Group Type ACTIVE_COMPARATOR

other workshop

Intervention Type OTHER

other workshop: discussion group, dance and body Expression

control group

Rate of oxytocin of the control group

Group Type OTHER

No intervention

Intervention Type OTHER

control group

Interventions

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olfactory workshop

olfactory workshop

Intervention Type OTHER

other workshop

other workshop: discussion group, dance and body Expression

Intervention Type OTHER

No intervention

control group

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondation Lenval

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florence ASKENAZY, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux pediatriques CHU de Nice Fondation Lenval

Locations

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Fondation Lenval Hôpitaux pediatriques CHU de Nice Fondation Lenval

Nice, , France

Site Status

Countries

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France

Other Identifiers

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14-AOI-06

Identifier Type: -

Identifier Source: org_study_id

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