- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06211517
Drugs Experience for Adolescents With Anorexia (E3P)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marie BENHAMMANI-GODARD
- Phone Number: 00 33 1 58 41 11 90
- Email: marie.godard@aphp.fr
Study Contact Backup
- Name: Maude Ludot-Gregoire, MD, psychiatrist
- Phone Number: 00 33 1 58 41 28 41
- Email: maude.ludot@aphp.fr
Study Locations
-
-
IDF
-
Paris, IDF, France, 75014
- Recruiting
- Maison de Solenn Maison des Adolescents, Cochin Hospital
-
Contact:
- Marie Rose Moro, MD, PhD
- Phone Number: 00 33 1 58 41 28 01
- Email: marie-moro.moro@aphp.fr
-
Contact:
- Sophie Wery
- Phone Number: 00 33 1 58 41 28 01
- Email: maude.ludot@aphp.fr
-
Principal Investigator:
- Maude LUDOT-GREGOIRE, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adolescents
Adolescents suffering from anorexia nervosa 12 to 25 years
|
Semi-structured interviews with visual mediations / An hour-long interview
Other Names:
|
|
Parents
Parents whose adolescents suffer from anorexia nervosa
|
Semi-structured interviews with visual mediations / An hour-long interview
Other Names:
|
|
Healthcare professionals
Healthcare professionals in charge of adolescents suffering from anorexia nervosa
|
Semi-structured interviews
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Day of inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Semi-structured interview
Time Frame: Day of inclusion
|
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)
|
Day of inclusion
|
|
Semi-structured interview
Time Frame: Day of inclusion
|
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)
|
Day of inclusion
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Corinne Blanchet, MD, Cochin Hospital (maison de Solenn)
- Study Director: Marie Rose Moro, MD, PhD, Cochin Hospital (maison de Solenn)
- Principal Investigator: Maude Ludot-Gregoire, MD, Cochin Hospital (maison de Solenn)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP230062
- 2022-A02141-42 (Other Identifier: France : Ministry of Health)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adolescent
-
University of CoimbraRecruitingAdolescent Behavior | Adolescent - Emotional ProblemPortugal
-
National Institute of Environmental Health Sciences...RecruitingAdolescent Health | Pediatrics | Adolescent Development | Reproductive Physiological ProcessesUnited States
-
University of MinnesotaNational Institute on Minority Health and Health Disparities (NIMHD); SoLaHmoCompletedAdolescent Health | Adolescent School Connectedness | Community Based Participatory Research MethodsUnited States
-
World Health OrganizationLondon School of Hygiene and Tropical Medicine; University of Ghana; Biomedical... and other collaboratorsRecruitingHealth-Related Behavior | Adolescent Behavior | Adolescent Development | Health Care Seeking BehaviorGhana, Tanzania, Zimbabwe
-
The Hong Kong Polytechnic UniversityNot yet recruiting
-
Aksaray UniversityEskisehir Osmangazi UniversityRecruiting
-
Eastern Mediterranean UniversityRecruiting
-
The Hong Kong Polytechnic UniversityNot yet recruiting
-
Eunice Kennedy Shriver National Institute of Child...Completed
-
Friends Research Institute, Inc.Conrad N. Hilton FoundationCompletedAdolescent Behavior | Adolescent Health ServicesUnited States
Clinical Trials on Semi-structured interviews with visual mediations
-
Institut Paoli-CalmettesNot yet recruiting
-
Indiana UniversityPatient-Centered Outcomes Research InstituteCompletedColorectal Cancer ScreeningUnited States
-
Assistance Publique - Hôpitaux de ParisRecruiting
-
Centre Hospitalier Universitaire de Saint EtienneL'École Nationale des Solidarités, de l'Encadrement et de l'Intervention...RecruitingPsychiatric HospitalizationFrance
-
Hasselt UniversityNot yet recruiting
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker CochinCompletedChronic (Non-malignant) Musculoskeletal PainFrance
-
Region SkaneLund UniversityCompletedSuicidal Ideation | Self-Harm, Deliberate | Self Injurious Behavior Without Suicidal IntentSweden
-
University of New MexicoSociety of Family PlanningWithdrawnPregnancy TerminationUnited States
-
Fundació Institut de Recerca de l'Hospital de la...UnknownChemotherapy-induced AlopeciaSpain
-
University of NimesNot yet recruitingCancer Colorectal | Hypnosis, AnimalFrance