Clinical trial NCT06211517: Drugs Experience for Adolescents With Anorexia
Official title: Subjective Experience of Psychotropic Drugs Among Adolescents (Their Parents and Professionals) With Anorexia Nervosa
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anorexia Nervosa
Psychotropic Drugs
Adolescent
Keywords: Adolescents
Anorexia nervosa
Psychotropic drugs
Qualitative research
Thematic analysis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescent medicine department in Cochin hospital

Brief 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 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:

1. 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.
2. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Semi-structured interview
timeFrame: Day of inclusion
Secondary outcomes:
measure: Semi-structured interview
timeFrame: Day of inclusion
measure: Semi-structured interview
timeFrame: Day of inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Maison de Solenn Maison des Adolescents, Cochin Hospital
state: IDF
Study officials:
affiliation: Cochin Hospital (maison de Solenn)
name: Corinne Blanchet, MD
role: STUDY_DIRECTOR
affiliation: Cochin Hospital (maison de Solenn)
name: Marie Rose Moro, MD, PhD
role: STUDY_DIRECTOR
affiliation: Cochin Hospital (maison de Solenn)
name: Maude Ludot-Gregoire, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.