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Completed

NCT Number: NCT02333500

Oxytocin and Incitement to Use Olfactory Stimuli in Restrictive Anorexia Nervosa

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.

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Key information

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondation Lenval Hôpitaux pediatriques CHU de Nice Fondation Lenval

Nice, 06200, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

olfactory workshop

Other

olfactory workshop

other workshop

Other

other workshop: discussion group, dance and body Expression

No intervention

Other

control group

Primary outcomes

  1. Score "Wanting" to olfactory stimuli

    Time frame: at 3 months

Secondary outcomes

  1. Oxytocin serum level

    Time frame: at 3 months

  2. Body mass index

    Time frame: at 3 months

  3. Scores to clinical scales

    Time frame: at 3 months

  4. Scores to hedonicity scale

    Time frame: at 3 months

  5. Scores to "liking"-"wanting" tests

    Time frame: at 3 months

Sponsors and collaborators

Lead sponsor

Fondation Lenval

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 7, 2015
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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