NCT04481165

Brief Summary

The purpose of this study is to explore the experience of adolescents suffering from anorexia nervosa confronted with the prescription of antidepressants

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

July 31, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2020

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

July 17, 2020

Last Update Submit

September 5, 2025

Conditions

Adolescents Cared for Anorexia Nervosa at Maison de Solenn

Keywords

Anorexia nervosaAdolescentsAntidepressive agents

Outcome Measures

Primary Outcomes (1)

  • 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

    At the time of inclusion (Day 0)

Study Arms (1)

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

Other: Survey

Interventions

SurveyOTHER

Oral interview and written questions

Adolescents with anorexia nervosa

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adolescents (between 12 and 25 years) suffer from anorexia nervosa, at the Maison de Solenn, Cochin Hospital, Paris, France

You may qualify if:

  • 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

You may not qualify if:

  • Atypical eating disorder that do not meet DSM-5 criteria for restrictive anorexia nervosa
  • Body Mass Index \< 15
  • Prescribed for another antidepressant than SSRIs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maison de Solenn / Cochin Hospital

Paris, 75014, France

Location

Related Publications (3)

  • 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.

    PMID: 27452149BACKGROUND

  • 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.

    PMID: 23219056BACKGROUND

  • 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.

    PMID: 35444576BACKGROUND

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Maude LUDOT, Psychiatrist

    APHP, Hôpital Cochin, Maison de Solenn, F-75014 Paris, France

    PRINCIPAL INVESTIGATOR

  • Marie-Rose MORO, PU-PH

    APHP, Hôpital Cochin, Maison de Solenn, F-75014 Paris, France

    STUDY CHAIR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 22, 2020

Study Start

July 31, 2020

Primary Completion

October 20, 2020

Study Completion

October 20, 2020

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

* 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.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
6 months after publication
Access Criteria
Interviews will be analysed with a qualitative methodology (Interpretative Phenomenological Analysis) \- Emergent themes will be presented.

Locations

FR(1)