AnorexiaNCT02333500
Oxytocin and Incitement to Use Olfactory Stimuli in Restrictive Anorexia Nervosa
A study testing olfactory workshop and other workshop in people with Anorexia, run by Fondation Lenval at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anorexia
- What is being tested?
- olfactory workshop and other workshop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 11 Feb 2015to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Fondation Lenval Hôpitaux pediatriques CHU de Nice Fondation Lenval
Nice, 06200
About this study
Official title: 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.
Read the 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
- Conditions
- Anorexia
- Being tested
- olfactory workshop, other workshop, No intervention
- Medical subject headings
- Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olfactory workshopOther
olfactory workshop
other workshopOther
other workshop: discussion group, dance and body Expression
No interventionOther
control group
| Study group | Role | What they receive |
|---|---|---|
| olfactory workshop | Experimental | Influence of sensory therapy on the rate of oxytocin Receives: Other: olfactory workshop |
| other workshop | Active comparator | Influence of other workshop on the rate of oxytocin Receives: Other: other workshop |
| control group | Other | Rate of oxytocin of the control group Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score "Wanting" to olfactory stimuli
Measured: at 3 months
Secondary outcomes (5)
Oxytocin serum level
Measured: at 3 months
Body mass index
Measured: at 3 months
Scores to clinical scales
Measured: at 3 months
Scores to hedonicity scale
Measured: at 3 months
Scores to "liking"-"wanting" tests
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study start11 Feb 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnorexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence ASKENAZY, PU-PH, Principal investigator, Hôpitaux pediatriques CHU de Nice Fondation Lenval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333500
- Sponsor's protocol ID
- 14-AOI-06
- Status last verified
- Jul 2018
- First submitted
- 26 Dec 2014
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: a Comparative Study Between Serum Levels of Oxytocin and Incitement to Use Olfactory Stimuli in Restrictive Anorexia Nervosa in Adolescents
- ClinicalTrials.gov ID
- NCT02333500
- Acronym / sponsor ID
- 14-AOI-06
- Conditions
- Anorexia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 11 Feb 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| olfactory workshop | Experimental | Other: olfactory workshopInfluence of sensory therapy on the rate of oxytocin |
| other workshop | Active comparator | Other: other workshopInfluence of other workshop on the rate of oxytocin |
| control group | Other | Other: No interventionRate of oxytocin of the control group |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Medical-Review
- Female or male -Sexe,
- 11 to 18 years
- Anorexia nervosa diagnosed according to the criteria DSM V
- Outpatient care or hospitalization
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olfactory workshopolfactory workshop | Other | olfactory workshop |
| other workshopother workshop: discussion group, dance and body Expression | Other | other workshop |
| No interventioncontrol group | Other | control group |
Primary outcome
Score "Wanting" to olfactory stimuli
Time frame: at 3 months
5 secondary outcomes
Oxytocin serum level
Time frame: at 3 months
Body mass index
Time frame: at 3 months
Scores to clinical scales
Time frame: at 3 months
Scores to hedonicity scale
Time frame: at 3 months
Scores to "liking"-"wanting" tests
Time frame: at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence ASKENAZY, PU-PH principal investigator
Hôpitaux pediatriques CHU de Nice Fondation Lenval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing olfactory workshop and other workshop in people with Anorexia, run by Fondation Lenval at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score "Wanting" to olfactory stimuli (time frame: at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.