NCT02333500

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

February 11, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 26, 2019

Status Verified

July 1, 2018

Enrollment Period

3.9 years

First QC Date

December 26, 2014

Last Update Submit

February 25, 2019

Conditions

Anorexia

Outcome Measures

Primary Outcomes (1)

  • Score "Wanting" to olfactory stimuli

    at 3 months

Secondary Outcomes (5)

  • 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

Study Arms (3)

olfactory workshop

EXPERIMENTAL

Influence of sensory therapy on the rate of oxytocin

Other: olfactory workshop

other workshop

ACTIVE COMPARATOR

Influence of other workshop on the rate of oxytocin

Other: other workshop

control group

OTHER

Rate of oxytocin of the control group

Other: No intervention

Interventions

olfactory workshopOTHER

olfactory workshop

olfactory workshop
other workshopOTHER

other workshop: discussion group, dance and body Expression

other workshop
No interventionOTHER

control group

control group

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Medical-Review
  • Female or male -Sexe,
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Lenval Hôpitaux pediatriques CHU de Nice Fondation Lenval

Nice, 06200, France

Location

MeSH Terms

Conditions

Anorexia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Florence ASKENAZY, PU-PH

    Hôpitaux pediatriques CHU de Nice Fondation Lenval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2014

First Posted

January 7, 2015

Study Start

February 11, 2015

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

February 26, 2019

Record last verified: 2018-07

Locations

FR(1)