Drugs Experience for Adolescents With Anorexia

Anorexia Nervosa Clinical Trial

— E3P  

Official title:

Subjective Experience of Psychotropic Drugs Among Adolescents (Their Parents and Professionals) With Anorexia Nervosa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06211517
• Other study ID #: APHP230062
• Secondary ID: 2022-A02141-42
• Status: Recruiting
• Start date: May 20, 2024
• Est. completion date: December 2027

Study information

• Verified date: June 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Maude Ludot-Gregoire, MD, psychiatrist
• Phone: 00 33 1 58 41 28 41
• Email: maude.ludot[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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 anorexia nervosa? In an adolescent medicine department.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adolescent
• Anorexia
• Anorexia Nervosa
• Psychotropic Drugs

Intervention

Other:
• Semi-structured interviews with visual mediations
Semi-structured interviews with visual mediations / An hour-long interview
• Semi-structured interviews
Semi-structured interviews

Locations

Country	Name	City	State
France	Maison de Solenn Maison des Adolescents, Cochin Hospital	Paris	IDF

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Day of inclusion
Secondary	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)	Day of inclusion
Secondary	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)	Day of inclusion

External Links

•   First qualitative study (E3A Protocol)