Anorexia NervosaE3PNCT06211517
Drugs Experience for Adolescents With Anorexia
An observational study of Anorexia Nervosa and Psychotropic Drugs, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to access to the experiences of adolescents, their parents and healthcare professionals regarding psychotropic drugs in anorexia nervosa. No preconceived ideas (according to qualitative methods) but a question: what are the participants' perceptions and experiences of psychotropic drugs in… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Psychotropic Drugs, Adolescent
- What is being tested?
- Semi-structured interviews with visual mediations and Semi-structured interviews
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2024to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adolescent medicine department in Cochin hospital
Who may be able to join
- Adolescents :
- Aged 12 to 25 years
- Suffering from anorexia nervosa (restrictive or mixed) according to DSM-5 (Diagnostic and Statistical Manual) criteria
- Received psychotropic drugs (antidepressant treatment and/or APA) during their care, either ongoing or discontinued before this study started
- Parents of adolescents suffering from anorexia nervosa for whom a psychotropic drug has been prescribed and whose adolescents meet inclusion criteria
- Healthcare Professionals working with adolescents suffering from eating disorders
Who cannot join
- Adolescents :
- Atypical eating disorder that does not meet the DSM-5 criteria for restrictive or mixed anorexia nervosa
- BMI<15
- Prescription of an antidepressant other than an SSRI (Selective Serotonin Reuptake Inhibitor)
- Prescription of an APA for the indication of psychotic symptoms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Maison de Solenn Maison des Adolescents, Cochin Hospital
Paris, IDF, 75014
Marie Rose Moro, MD, PhD, 00 33 1 58 41 28 01, marie-moro.moro@aphp.fr
Sophie Wery, 00 33 1 58 41 28 01, maude.ludot@aphp.fr
About this study
Official title: Subjective Experience of Psychotropic Drugs Among Adolescents (Their Parents and Professionals) With Anorexia Nervosa
The purpose of this study is to access to the experiences of adolescents, their parents and healthcare professionals regarding psychotropic drugs in anorexia nervosa.
No preconceived ideas (according to qualitative methods) but a question: what are the participants' perceptions and experiences of psychotropic drugs in anorexia nervosa? In an adolescent medicine department.
Read the detailed description
Psychotropic prescription is common to adolescents suffering from anorexia nervosa. A first qualitative study (E3A Protocol "Experience of adolescents with anorexia nervosa toward antidepressants") looked at the experience of antidepressants among 15 adolescents suffering from anorexia nervosa. Analysis of the interviews identified two meta-themes:
- Reactions to the proposal of antidepressant with an opposition phase (about the existence of depressive symptoms and about negative preconceptions) and need to share with family and other teenagers.
- Reactions to antidepressant use with ambivalence and an initial perception of coercion, and effects of antidepressants (psychological effects, effects on the body and on anorexia nervosa and effects perceived through the eyes of others).
Nine adolescents (out of 15) were also taking an atypical antipsychotic (APA) often prescribed in case of anorexia nervosa resistance.
The need to share with family about the proposal of antidepressant and the effects perceived through the eyes of others (including parent's eyes) lead us to take an interest in parents perceptions.
Two decisive periods were identified: What do healthcare professionals think about psychotropic treatments for anorexia nervosa in adolescence? How do they propose treatment?
Interviewing teenagers, their parents as well as healthcare professionals, will enable to access to the complexity of representations and experiences of these psychotropic drugs in anorexia nervosa.
- Conditions
- Anorexia Nervosa, Psychotropic Drugs, Adolescent
- Being tested
- Semi-structured interviews with visual mediations, Semi-structured interviews
- Keywords
- Adolescents, Anorexia nervosa, Psychotropic drugs, Qualitative research, Thematic analysis
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviews with visual mediationsOther
Also called Qualitative interviews
Semi-structured interviews with visual mediations / An hour-long interview
Semi-structured interviewsOther
Also called Qualitative interviews
Semi-structured interviews
| Study group | Role | What they receive |
|---|---|---|
| Adolescents | Adolescents suffering from anorexia nervosa 12 to 25 years Receives: Other: Semi-structured interviews with visual mediations | |
| Parents | Parents whose adolescents suffer from anorexia nervosa Receives: Other: Semi-structured interviews with visual mediations | |
| Healthcare professionals | Healthcare professionals in charge of adolescents suffering from anorexia nervosa Receives: Other: Semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-structured interview
Themes describing adolescent experiences regarding psychotropic drugs in anorexia nervosa - Emergence of themes describing participants' experience from analysis of qualitative interviews (with Interpretative Phenomenology Analysis methodology)
Measured: Day of inclusion
Secondary outcomes (2)
Semi-structured interview
Themes describing parents experiences regarding psychotropic drugs for their children suffering from anorexia nervosa - Emergence of themes describing participants' experience from analysis of qualitative interviews (with Interpretative Phenomenology Analysis methodology)
Measured: Day of inclusion
Semi-structured interview
Themes describing healthcare professionals experiences regarding psychotropic drugs for adolescents suffering from anorexia nervosa - Emergence of themes describing participants' experience from analysis of qualitative interviews (with Interpretative Phenomenology Analysis methodology)
Measured: Day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start20 May 2024
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
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
- Corinne Blanchet, MD, Study director, Cochin Hospital (maison de Solenn)Marie Rose Moro, MD, PhD, Study director, Cochin Hospital (maison de Solenn)Maude Ludot-Gregoire, MD, Principal investigator, Cochin Hospital (maison de Solenn)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211517
- Sponsor's protocol ID
- APHP230062
- Other IDs
- 2022-A02141-42
- Acronym
- E3P
- Status last verified
- Sep 2025
- First submitted
- 8 Jan 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ludot-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 Psychotropic Drugs Among Adolescents (Their Parents and Professionals) With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT06211517
- Acronym / sponsor ID
- E3P / APHP230062
- Conditions
- Anorexia Nervosa, Psychotropic Drugs, Adolescent
- Keywords
- Adolescents, Anorexia nervosa, Psychotropic drugs, Qualitative research, Thematic analysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 20 May 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Jan 2024 (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 access to the experiences of adolescents, their parents and healthcare professionals regarding psychotropic drugs in anorexia nervosa.
No preconceived ideas (according to qualitative methods) but a question: what are the participants' perceptions and experiences of psychotropic drugs in anorexia nervosa? In an adolescent medicine department.
Detailed description
Psychotropic prescription is common to adolescents suffering from anorexia nervosa. A first qualitative study (E3A Protocol "Experience of adolescents with anorexia nervosa toward antidepressants") looked at the experience of antidepressants among 15 adolescents suffering from anorexia nervosa. Analysis of the interviews identified two meta-themes:
- Reactions to the proposal of antidepressant with an opposition phase (about the existence of depressive symptoms and about negative preconceptions) and need to share with family and other teenagers.
- Reactions to antidepressant use with ambivalence and an initial perception of coercion, and effects of antidepressants (psychological effects, effects on the body and on anorexia nervosa and effects perceived through the eyes of others).
Nine adolescents (out of 15) were also taking an atypical antipsychotic (APA) often prescribed in case of anorexia nervosa resistance.
The need to share with family about the proposal of antidepressant and the effects perceived through the eyes of others (including parent's eyes) lead us to take an interest in parents perceptions.
Two decisive periods were identified: What do healthcare professionals think about psychotropic treatments for anorexia nervosa in adolescence? How do they propose treatment?
Interviewing teenagers, their parents as well as healthcare professionals, will enable to access to the complexity of representations and experiences of these psychotropic drugs in anorexia nervosa.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adolescents | – | Other: Semi-structured interviews with visual mediationsAdolescents suffering from anorexia nervosa 12 to 25 years |
| Parents | – | Other: Semi-structured interviews with visual mediationsParents whose adolescents suffer from anorexia nervosa |
| Healthcare professionals | – | Other: Semi-structured interviewsHealthcare professionals in charge of adolescents suffering from anorexia nervosa |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adolescent medicine department in Cochin hospital
Key inclusion criteria (6 listed)
- Aged 12 to 25 years
- Suffering from anorexia nervosa (restrictive or mixed) according to DSM-5 (Diagnostic and Statistical Manual) criteria
- Received psychotropic drugs (antidepressant treatment and/or APA) during their care, either ongoing or discontinued before this study started
- Parents of adolescents suffering from anorexia nervosa for whom a psychotropic drug has been prescribed and whose adolescents meet inclusion criteria
- Healthcare Professionals working with adolescents suffering from eating disorders
Key exclusion criteria (5 listed)
- Atypical eating disorder that does not meet the DSM-5 criteria for restrictive or mixed anorexia nervosa
- BMI<15
- Prescription of an antidepressant other than an SSRI (Selective Serotonin Reuptake Inhibitor)
- Prescription of an APA for the indication of psychotic symptoms
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 |
|---|---|---|
| Semi-structured interviews with visual mediationsAlso: Qualitative interviewsSemi-structured interviews with visual mediations / An hour-long interview | Other | Adolescents, Parents |
| Semi-structured interviewsAlso: Qualitative interviewsSemi-structured interviews | Other | Healthcare professionals |
Primary outcome
Semi-structured interview
Time frame: Day of inclusion
Themes describing adolescent experiences regarding psychotropic drugs in anorexia nervosa - Emergence of themes describing participants' experience from analysis of qualitative interviews (with Interpretative Phenomenology Analysis methodology)
2 secondary outcomes
Semi-structured interview
Time frame: Day of inclusion
Semi-structured interview
Time frame: Day of inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Background: 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.
- First qualitative study (E3A Protocol)Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Anorexia Nervosa
RecruitingObservational study
Exploratory Study of Sensory Profile and Coping Strategies in Eating Disorders
Eating Disorders, Anorexia Nervosa
Recruiting
Cerebellar tDCS Stimulation in Children and Adult Women With Anorexia Nervosa Disorder
Anorexia Nervosa
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Recruiting
Identification of Anti-HIF 1alpha Autoantibodies in Patients With Anorexia Nervosa and Characterization of Their Pathogenic Potential in Undernutrition-associated Hepatic Cytolysis
Hepatic Cytolysis
Active, not recruiting
Neuroscience-informed Treatment to Remotely Target Reward Mechanisms in Post-acute Anorexia Nervosa
Anorexia Nervosa
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.
Corinne Blanchet, MD study director
Cochin Hospital (maison de Solenn)
Marie Rose Moro, MD, PhD study director
Cochin Hospital (maison de Solenn)
Maude Ludot-Gregoire, MD principal investigator
Cochin Hospital (maison de Solenn)
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 Anorexia Nervosa and Psychotropic Drugs, 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 6 inclusion and 5 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maude Ludot-Gregoire, MD, psychiatrist (00 33 1 58 41 28 41, maude.ludot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semi-structured interview (time frame: Day of inclusion). 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 NCT06211517, which also lists 1 linked publication.
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.