Adolescents Cared for Anorexia Nervosa at Maison de SolennE3ANCT04481165
Experience of Adolescents With Anorexia Nervosa Towards Antidepressants
An observational study of Adolescents Cared for Anorexia Nervosa at Maison de Solenn, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to explore the experience of adolescents suffering from anorexia nervosa confronted with the prescription of antidepressants Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Adolescents Cared for Anorexia Nervosa at Maison de Solenn
- What is being tested?
- Survey
- Type of treatment
- Pill or oral medicine
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jul 2020to 20 Oct 2020
- Phase
- Observational
- 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 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents (between 12 and 25 years) suffer from anorexia nervosa, at the Maison de Solenn, Cochin Hospital, Paris, France
Who may be able to join
- Adolescents aged 12 to 25
- Suffering from anorexia nervosa [according to DSM-5 criteria]
- Has been prescribed for a type of SSRIs antidepressant (still ongoing or interrupted at the time of the interview)
- Non-opposition to the study
Who cannot join
- Atypical eating disorder that do not meet DSM-5 criteria for restrictive anorexia nervosa
- Body Mass Index < 15
- Prescribed for another antidepressant than SSRIs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subjective Experience of Adolescents Suffering From Anorexia Nervosa With Antidepressants
The purpose of this study is to explore the experience of adolescents suffering from anorexia nervosa confronted with the prescription of antidepressants
Read the detailed description
In our adolescent psychiatric unit, antidepressant's prescription is common during the care pathway for adolescents with anorexia nervosa.
The literature highlights a paradox between scientific data and clinical practice, based on expert consensus. There are a very few qualitative studies in this subject and none of them concern adolescents.
The purpose of this qualitative study is to explore the experience and opinion of adolescents suffering from anorexia nervosa confronted with the prescription of antidepressants
- Being tested
- Survey
- Keywords
- Anorexia nervosa, Adolescents, Antidepressive agents
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Oral interview and written questions
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with anorexia nervosa | Adolescents from 12 to 25 year old, cared for anorexia nervosa at the Maison de Solenn (Cochin hospital, Paris, France) et for whom antidepressive agents have been prescribed Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative data / Experience of taking anidepressants
Subjective experience of adolescents with anorexia nervosa about prescription of antidepressants and their effects will be obtained during the grid interview and through their describing to written questions
Measured: At the time of inclusion (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start31 Jul 2020
- Primary completion20 Oct 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adolescents Cared for Anorexia Nervosa at Maison de SolennStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Maude LUDOT, Psychiatrist, Principal investigator, APHP, Hôpital Cochin, Maison de Solenn, F-75014 Paris, FranceMarie-Rose MORO, PU-PH, Study chair, APHP, Hôpital Cochin, Maison de Solenn, F-75014 Paris, FranceCorinne BLANCHET, PH, Study director, APHP, Hôpital Cochin, Maison de Solenn, F-75014 Paris, FranceJonathan LACHAL, PHU, Study director, APHP, Hôpital Cochin, Maison de Solenn, F-75014 Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481165
- Sponsor's protocol ID
- APHP200104
- Acronym
- E3A
- Status last verified
- Sep 2025
- First submitted
- 17 Jul 2020
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * Use of a treatment database, named Actipidos * Interview recording on a Dictaphone \[kept all over the study in a locked drawer in a medical office at the Maison de Solenn, and then destroyed\]. * Verbatim transcription, on a word-formatted file from a computer in a medical office at the Maison de Solenn; computer secured by a password. * Transcripts will be anonymized with an identical number as soon as they are created; no non-anonymized data records will be kept beyond the end of the study.
Publications
Leble N, Radon L, Rabot M, Godart N. [Depressive symptoms during anorexia nervosa: State of the art and consequences for an appropriate use of antidepressants]. Encephale. 2017 Feb;43(1):62-68. doi: 10.1016/j.encep.2016.02.017. Epub 2016 Jul 21. French.
PubMed 27452149Anderson C, Roy T. Patient experiences of taking antidepressants for depression: a secondary qualitative analysis. Res Social Adm Pharm. 2013 Nov-Dec;9(6):884-902. doi: 10.1016/j.sapharm.2012.11.002. Epub 2012 Dec 4.
PubMed 23219056Ludot-Gregoire M, David V, Carretier E, Lachal J, Moro MR, Blanchet C. Subjective Experience of Antidepressant Prescription Among Adolescents With Anorexia Nervosa. Front Psychiatry. 2022 Apr 4;13:770903. doi: 10.3389/fpsyt.2022.770903. eCollection 2022.
PubMed 35444576
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjective Experience of Adolescents Suffering From Anorexia Nervosa With Antidepressants
- ClinicalTrials.gov ID
- NCT04481165
- Acronym / sponsor ID
- E3A / APHP200104
- Keywords
- Anorexia nervosa, Adolescents, Antidepressive agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 22 Jul 2020 (actual)
- 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 explore the experience of adolescents suffering from anorexia nervosa confronted with the prescription of antidepressants
Detailed description
In our adolescent psychiatric unit, antidepressant's prescription is common during the care pathway for adolescents with anorexia nervosa.
The literature highlights a paradox between scientific data and clinical practice, based on expert consensus. There are a very few qualitative studies in this subject and none of them concern adolescents.
The purpose of this qualitative study is to explore the experience and opinion of adolescents suffering from anorexia nervosa confronted with the prescription of antidepressants
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents with anorexia nervosa | – | Other: SurveyAdolescents from 12 to 25 year old, cared for anorexia nervosa at the Maison de Solenn (Cochin hospital, Paris, France) et for whom antidepressive agents have been prescribed |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents (between 12 and 25 years) suffer from anorexia nervosa, at the Maison de Solenn, Cochin Hospital, Paris, France
Key inclusion criteria (4 listed)
- Adolescents aged 12 to 25
- Suffering from anorexia nervosa [according to DSM-5 criteria]
- Has been prescribed for a type of SSRIs antidepressant (still ongoing or interrupted at the time of the interview)
- Non-opposition to the study
Key exclusion criteria (3 listed)
- Atypical eating disorder that do not meet DSM-5 criteria for restrictive anorexia nervosa
- Body Mass Index < 15
- Prescribed for another antidepressant than SSRIs
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 |
|---|---|---|
| SurveyOral interview and written questions | Other | Adolescents with anorexia nervosa |
Primary outcome
Qualitative data / Experience of taking anidepressants
Time frame: At the time of inclusion (Day 0)
Subjective experience of adolescents with anorexia nervosa about prescription of antidepressants and their effects will be obtained during the grid interview and through their describing to written questions
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 12 Sep 2025.
- Background: PubMed 27452149Leble N, Radon L, Rabot M, Godart N. [Depressive symptoms during anorexia nervosa: State of the art and consequences for an appropriate use of antidepressants]. Encephale. 2017 Feb;43(1):62-68. doi: 10.1016/j.encep.2016.02.017. Epub 2016 Jul 21. French.
- Background: PubMed 23219056Anderson C, Roy T. Patient experiences of taking antidepressants for depression: a secondary qualitative analysis. Res Social Adm Pharm. 2013 Nov-Dec;9(6):884-902. doi: 10.1016/j.sapharm.2012.11.002. Epub 2012 Dec 4.
- Results publication: PubMed 35444576Ludot-Gregoire M, David V, Carretier E, Lachal J, Moro MR, Blanchet C. Subjective Experience of Antidepressant Prescription Among Adolescents With Anorexia Nervosa. Front Psychiatry. 2022 Apr 4;13:770903. doi: 10.3389/fpsyt.2022.770903. eCollection 2022.
- Individual participant dataSharing planned: Yes. * Use of a treatment database, named Actipidos * Interview recording on a Dictaphone [kept all over the study in a locked drawer in a medical office at the Maison de Solenn, and then destroyed]. * Verbatim transcription, on a word-formatted file from a computer in a medical office at the Maison de Solenn; computer secured by a password. * Transcripts will be anonymized with an identical number as soon as they are created; no non-anonymized data records will be kept beyond the end of the study.
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.
Maude LUDOT, Psychiatrist principal investigator
APHP, Hôpital Cochin, Maison de Solenn, F-75014 Paris, France
Marie-Rose MORO, PU-PH study chair
APHP, Hôpital Cochin, Maison de Solenn, F-75014 Paris, France
Corinne BLANCHET, PH study director
APHP, Hôpital Cochin, Maison de Solenn, F-75014 Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescents Cared for Anorexia Nervosa at Maison de Solenn, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 3 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 12 Sep 2025. 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?
Qualitative data / Experience of taking anidepressants (time frame: At the time of inclusion (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04481165, which also lists 3 linked publications.
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 12 Sep 2025.