NCT06874348

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Oct 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Progress79%
Oct 2024Oct 2026

Study Start

First participant enrolled

October 24, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

1.9 years

First QC Date

February 27, 2025

Last Update Submit

March 11, 2025

Conditions

Anorexia NervosaBulimia Nervosa

Keywords

resting state fMRIlongitudinal evaluation

Outcome Measures

Primary Outcomes (6)

  • 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

Secondary Outcomes (4)

  • Change of measure of interhemispheric connectivity between corresponding areas in fMRI (Voxelwise Homotopic Connectivity - VMHC)

    baseline, 12 months post-enrollment

  • Change in Regional Homogeneity (ReHo) index

    baseline, 12 months post-enrollment

  • Chiange in amplitude of low-frequency fluctuations (ALFF) and fractional amplitude of low-frequency fluctuations (fALFF) of the blood oxygen-level dependent (BOLD) signal in fMRI data

    baseline, 12 months post-enrollment

  • Change in connection degree between each node and other nodes (Degree of Centrality - DC) in the network in the brain.

    Baseline - 12 months post-enrollment

Study Arms (4)

Anorexia Nervosa - minors

Diagnostic Test: structural and functional MRI

Bulimia Nervosa - minors

Diagnostic Test: structural and functional MRI

Anorexia Nervosa - adults

Diagnostic Test: structural and functional MRI

Bulimia Nervosa - adults

Diagnostic Test: structural and functional MRI

Interventions

structural and functional MRIDIAGNOSTIC_TEST

structural and functional MRI

Anorexia Nervosa - adultsAnorexia Nervosa - minorsBulimia Nervosa - adultsBulimia Nervosa - minors

Eligibility Criteria

Age12 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Anorexia Nervosa or Bulimia Nervosa patients between 12 and 40 years old

You may qualify if:

  • Female sex
  • Age between 12 and 40 years old
  • Current diagnosis of Anorexia Nervosa or Bulimia Nervosa according to DSM-5-TR.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Azienda Ospedaliero-Universitaria Careggi, Firenze

Florence, Italy

RECRUITING

Meyer Children's Hospital IRCCS

Florence, Italy

RECRUITING

MeSH Terms

Conditions

Anorexia NervosaBulimia Nervosa

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Tiziana Pisano

CONTACT

0039 055 5662907t.pisano@meyer.it

Giovanni Castellini

CONTACT

0039 055 794 7478giovanni.castellini@unifi.it

Study Design

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

Study Record Dates

First Submitted

February 27, 2025

First Posted

March 13, 2025

Study Start

October 24, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)