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Recruiting Observational

Functional MRI During Resting State in Patients with Eating Disorders

NCT06874348 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-10-24
Last updated
2025-03-13

Condition(s) studied

Anorexia NervosaBulimia Nervosa

Investigational drug(s) / intervention(s)

structural and functional MRI

structural and functional MRI: structural and functional MRI

Study summary

The goal of this observational study is to learn if clinical and neurophysiological characteristics dynamics may follow similar trends in a longitudinal characterization of patients with a diagnosis of an eating disorder.

The primary hypothesis is that the reversal of Functional Magnetic Resonance Imaging (fMRI) baseline alternations is positively associated with symptomatic amelioration.

The secondary hypothesis is that the degree of (f)MRI baseline alternations is positively associated with symptoms.

Participants will be asked to complete psychometric questionnaires, perform a fMRI and be recalled at 12 months for a follow-up.

Eligibility

Sex
FEMALE
Min age
12 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria: * Female sex * Age between 12 and 40 years old * Current diagnosis of Anorexia Nervosa or Bulimia Nervosa according to DSM-5-TR. Exclusion Criteria: * Previous or current diagnosis of schizophrenia or bipolar disorder, * Acute psychosis * Substance abuse * Severe medical comorbidities (hypercapnia, severe hypertension, cardiac arrhythmia, organ failure) * incapacity to grant written or verbal consent

Primary outcome measure(s)

  • Change in cortical thickness — baseline, 12 months post-enrollment
  • Weight restoration — baseline - 12 months post-enrollment
  • Child Behavior Checklist (CBCL) score — Baseline - 12 months post enrollment
  • Children's Depression Inventory (CDI) score — baseline, 12 months post-enrollment
  • Multidimensional Anxiety Scale for Children (MASC) — Baseline - 12 months post-enrollment
  • Eating Disorder Inventory (EDI) psychometric score — Baseline - 12 months post-enrollment

Trial sites (2)

FacilityCityRegionStatus
Azienda Ospedaliero-Universitaria Careggi, Firenze Florence Italy Recruiting
Meyer Children's Hospital IRCCS Florence Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06874348 on ClinicalTrials.gov ↗ ← All trials in Italy