Anorexia NervosaNarcisseNCT01964456
"Self-consciousness and the Inter-subjective Body"
A study testing Joint perception task, Body Shape Questionnaire and Measure of the heart rate in people with Anorexia Nervosa, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
The purpose of this study is to demonstrate that bodily self-consciousness is subjectively and inter-subjectively constituted and that some dimensions of the bodily self-consciousness are impaired in Anorexia nervosa. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Joint perception task, Body Shape Questionnaire and Measure of the heart rate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Jun 2014
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women
- From 18 to 35 years old
- Understanding and being fluent in French
- Hospitalized or followed in consultation for Anorexia nervosa (Restrictive Anorexia or Purge according to the MINI)
- Informed consent signed by the patient
- Diagnosis of Anorexia according to her psychiatrist (and confirmed by the DSM IV) with a BMI between 11 and 18.
Who cannot join
- Somatic Pathology (cancer, cardiac, renal or respiratory insufficiency, central neurological affection), evolutionary, or risking to be life-threatening within less than year
- Neurological Histories (neurological pathology susceptible to alter attentionnal capacities or field of vision and vision of colors (Encephalitis, Degenerative Brain tumour (méningiome, gliome, astrocytome), Congenital Neurodegenerative Pathology, Multiple sclerosis, Amyotrophic side Hardening, Epilepsy)
- Neuroleptic or psychotropic Treatment in doses inferring a slumber, a disorder of the concentration
- Dyschromatopsie
- No insurance
- Comorbidity of psychiatric type
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Narcisse & Echo : Self-consciousness and the Inter-subjective Body"
The purpose of this study is to demonstrate that bodily self-consciousness is subjectively and inter-subjectively constituted and that some dimensions of the bodily self-consciousness are impaired in Anorexia nervosa.
Read the detailed description
Anorexia nervosa is a severe psychiatric disorder, with high level of mortality. Anorexic patients often experience a serious disturbance in body and their own shape perception.
We hypothesize that bodily self-consciousness is co-constituted by four subjective dimensions which are all inter-subjectively open: in encountering others, one's body is experienced as
- objectified,
- the bearer of inter-subjective feelings,
- an inter-subjective agent and
- the anchor of an inter-subjectively negotiated perspective.
Across several experiments, we sought to determine which dimension of bodily self-consciousness is altered in Anorexia Nervosa compared to healthy subjects.
- Conditions
- Anorexia Nervosa
- Being tested
- Joint perception task, Body Shape Questionnaire, Measure of the heart rate
- Keywords
- Bodily self-consciousness, intersubjective body, Anorexia Nervosa, Joint perception task, Interoceptive awareness
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint perception taskOther
Body Shape QuestionnaireBehavioural
Measure of the heart rateOther
| Study group | Role | What they receive |
|---|---|---|
| Patients | Active comparator | Patients suffering of anorexia Receives: Other: Joint perception task; Behavioral: Body Shape Questionnaire; Other: Measure of the heart rate |
| Control | Placebo comparator | Subjects controls (not suffering of anorexia) Receives: Other: Joint perception task; Behavioral: Body Shape Questionnaire; Other: Measure of the heart rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint perception task
Recording of the ocular behaviour in anorectic during the joint perception task.
Measured: 1 week
Secondary outcomes (1)
Body Shape Questionnaire
Body Shape Questionnaire
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Collaborators
- The Volkswagen Foundation
- Responsible party
- Sponsor
- Investigators
- Mathias GOROG, MD, Principal investigator, CHSA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964456
- Sponsor's protocol ID
- D13-P001
- Acronym
- Narcisse
- Status last verified
- Feb 2015
- First submitted
- 14 Oct 2013
- Last updated
- 2 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Narcisse & Echo : Self-consciousness and the Inter-subjective Body"
- ClinicalTrials.gov ID
- NCT01964456
- Acronym / sponsor ID
- Narcisse / D13-P001
- Conditions
- Anorexia Nervosa
- Keywords
- Bodily self-consciousness, intersubjective body, Anorexia Nervosa, Joint perception task, Interoceptive awareness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Collaborators
- The Volkswagen Foundation
- Study start
- Nov 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Oct 2013 (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.
The purpose of this study is to demonstrate that bodily self-consciousness is subjectively and inter-subjectively constituted and that some dimensions of the bodily self-consciousness are impaired in Anorexia nervosa.
Detailed description
Anorexia nervosa is a severe psychiatric disorder, with high level of mortality. Anorexic patients often experience a serious disturbance in body and their own shape perception.
We hypothesize that bodily self-consciousness is co-constituted by four subjective dimensions which are all inter-subjectively open: in encountering others, one's body is experienced as
- objectified,
- the bearer of inter-subjective feelings,
- an inter-subjective agent and
- the anchor of an inter-subjectively negotiated perspective.
Across several experiments, we sought to determine which dimension of bodily self-consciousness is altered in Anorexia Nervosa compared to healthy subjects.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Active comparator | Other: Joint perception task, Behavioral: Body Shape Questionnaire, Other: Measure of the heart ratePatients suffering of anorexia |
| Control | Placebo comparator | Other: Joint perception task, Behavioral: Body Shape Questionnaire, Other: Measure of the heart rateSubjects controls (not suffering of anorexia) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women
- From 18 to 35 years old
- Understanding and being fluent in French
- Hospitalized or followed in consultation for Anorexia nervosa (Restrictive Anorexia or Purge according to the MINI)
- Informed consent signed by the patient
Key exclusion criteria (6 listed)
- Somatic Pathology (cancer, cardiac, renal or respiratory insufficiency, central neurological affection), evolutionary, or risking to be life-threatening within less than year
- Neurological Histories (neurological pathology susceptible to alter attentionnal capacities or field of vision and vision of colors (Encephalitis, Degenerative Brain tumour (méningiome, gliome, astrocytome), Congenital Neurodegenerative Pathology, Multiple sclerosis, Amyotrophic side Hardening, Epilepsy)
- Neuroleptic or psychotropic Treatment in doses inferring a slumber, a disorder of the concentration
- Dyschromatopsie
- No insurance
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 |
|---|---|---|
| Joint perception task | Other | Control, Patients |
| Body Shape Questionnaire | Behavioural | Control, Patients |
| Measure of the heart rate | Other | Control, Patients |
Primary outcome
Joint perception task
Time frame: 1 week
Recording of the ocular behaviour in anorectic during the joint perception task.
1 secondary outcome
Body Shape Questionnaire
Time frame: 1 week
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 2 Mar 2015.
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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.
Mathias GOROG, MD principal investigator
CHSA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joint perception task, Body Shape Questionnaire and Measure of the heart rate in people with Anorexia Nervosa, run by Centre Hospitalier St Anne 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 6 inclusion and 6 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 2 Mar 2015. 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. Some participants in this study may receive a placebo. 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?
Joint perception task (time frame: 1 week). 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 2 Mar 2015.