- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04481165
Experience of Adolescents With Anorexia Nervosa Towards Antidepressants (E3A)
Subjective Experience of Adolescents Suffering From Anorexia Nervosa With Antidepressants
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 75014
- Maison de Solenn / Cochin Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Atypical eating disorder that do not meet DSM-5 criteria for restrictive anorexia nervosa
- Body Mass Index < 15
- Prescribed for another antidepressant than SSRIs
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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
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Oral interview and written questions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative data / Experience of taking anidepressants
Time Frame: At the time of inclusion (Day 0)
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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
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At the time of inclusion (Day 0)
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Maude LUDOT, Psychiatrist, APHP, Hôpital Cochin, Maison de Solenn, F-75014 Paris, France
- Study Chair: Marie-Rose MORO, PU-PH, APHP, Hôpital Cochin, Maison de Solenn, F-75014 Paris, France
- Study Director: Corinne BLANCHET, PH, APHP, Hôpital Cochin, Maison de Solenn, F-75014 Paris, France
- Study Director: Jonathan LACHAL, PHU, APHP, Hôpital Cochin, Maison de Solenn, F-75014 Paris, France
Publications and helpful links
General 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.
- Anderson 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- APHP200104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
- 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.
IPD Sharing Time Frame
IPD Sharing Access Criteria
Interviews will be analysed with a qualitative methodology (Interpretative Phenomenological Analysis)
- Emergent themes will be presented.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
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.
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