ClinicalTrials.gg
RecruitingNCT06874348Updated Mar 13, 2025

Functional MRI During Resting State in Patients with Eating Disorders

An observational study in Anorexia Nervosa and Bulimia Nervosa, sponsored by Meyer Children's Hospital IRCCS. Recruiting at 2 sites in Italy. Open to female participants aged 12 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-03-13.

Sponsored by Meyer Children's Hospital IRCCS · Observational

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
12 Years to 40 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 30 studies in Anorexia Nervosa with a site in Italy — 10 open to participants now, 11 under way, none of them phase 3. Anorexia Nervosa · Italy.

Planned enrollment
12th of 18
50 · median 60
Started
2024
with 10 others
Observational
18 of 30
4 open now
Primary completion
2026-10
later than 6 of 10 live
Registered
25th of 30
by date
Lead sponsor
1 of 30
Meyer Children's Hospital IRCCS

Among the 30 studies in Anorexia Nervosa with a site in Italy, this one is the 12th largest by planned enrollment of the 18 observational ones that give a count, is one of 11 that started in 2024, is one of 18 observational ones, reaches primary completion later than 6 of the 10 other live ones, and was the 25th registered.

Anorexia Nervosa

469 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.

Browse Anorexia Nervosa studies →

Open to participants now

10 of the 30 studies in Anorexia Nervosa with a site in Italy are open now. Recruiting first, the newest first:

4 more — sign in →

All 10 open studies →

A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →

Who these studies take

Of the 83 Anorexia Nervosa studies recruiting now, 18 (22%) set no upper age limit and 61 (73%) stop at 75 or younger; 48 take children under 18; 26 take healthy volunteers.

This study: 12 Years to 40 Years · female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 30 studies in Anorexia Nervosa with a site in Italy, or all of them as a file.
02

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.

03

Conditions studied

  • Anorexia Nervosa
  • Bulimia Nervosa

Keywords

  • resting state fMRI
  • longitudinal evaluation
04

Who can participate

Ages eligible
12 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic teststructural and functional MRI

    structural and functional MRI

06

What researchers measure

Primary outcomes

  1. Change in cortical thickness

    Time frame: baseline, 12 months post-enrollment

  2. Weight restoration

    Time frame: baseline - 12 months post-enrollment

  3. Child Behavior Checklist (CBCL) score

    Time frame: Baseline - 12 months post enrollment

  4. Children's Depression Inventory (CDI) score

    Time frame: baseline, 12 months post-enrollment

  5. Multidimensional Anxiety Scale for Children (MASC)

    Time frame: Baseline - 12 months post-enrollment

  6. Eating Disorder Inventory (EDI) psychometric score

    Time frame: Baseline - 12 months post-enrollment

Secondary outcomes

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

    VMHC is a measure of interhemispheric connectivity between corresponding areas in fMRI. VMHC measures the level of symmetry, or correlation, between left/right pairs of voxels or brain areas.

    Time frame: baseline, 12 months post-enrollment

  2. Change in Regional Homogeneity (ReHo) index

    Time frame: baseline, 12 months post-enrollment

  3. 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

    Time frame: baseline, 12 months post-enrollment

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

    Time frame: Baseline - 12 months post-enrollment

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2024 (actual). Primary completion is estimated for Oct 2026, 24 months after the start.

Of 56 non-industry observational studies under Anorexia Nervosa, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 72. This study's planned 24 months is below that.

Counting every sponsor, half of 56 studies reached it within 38 months; a quarter within 16 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2025
First posted
Mar 13, 2025
StartActual
Oct 24, 2024
Primary completionEst.
Oct 2026
CompletionEst.
Oct 2026
Last update
Mar 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06874348
Lead sponsor
Meyer Children's Hospital IRCCS
Collaborators
Azienda Ospedaliero-Universitaria Careggi, Firenze
Responsible party
Sponsor
First posted
Mar 13, 2025
Start date
Oct 24, 2024
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Mar 13, 2025

Study contacts

Tiziana Pisano
Contact
t.pisano@meyer.it
0039 055 5662907
Giovanni Castellini
Contact
giovanni.castellini@unifi.it
0039 055 794 7478

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion