Functional MRI During Resting State in Patients with Eating Disorders

NCT ID: NCT06874348

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-24

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anorexia Nervosa Bulimia Nervosa

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Anorexia Nervosa - minors

structural and functional MRI

Intervention Type DIAGNOSTIC_TEST

structural and functional MRI

Bulimia Nervosa - minors

structural and functional MRI

Intervention Type DIAGNOSTIC_TEST

structural and functional MRI

Anorexia Nervosa - adults

structural and functional MRI

Intervention Type DIAGNOSTIC_TEST

structural and functional MRI

Bulimia Nervosa - adults

structural and functional MRI

Intervention Type DIAGNOSTIC_TEST

structural and functional MRI

Interventions

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structural and functional MRI

structural and functional MRI

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero-Universitaria Careggi

OTHER

Sponsor Role collaborator

Meyer Children's Hospital IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Azienda Ospedaliero-Universitaria Careggi, Firenze

Florence, , Italy

Site Status RECRUITING

Meyer Children's Hospital IRCCS

Florence, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Tiziana Pisano

Role: CONTACT

0039 055 5662907

Giovanni Castellini

Role: CONTACT

0039 055 794 7478

Facility Contacts

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Giovanni Castellini

Role: primary

0039 055 794 7478

Tiziana Pisano

Role: primary

0039 055 5662907

Other Identifiers

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RS-FMRI-ED

Identifier Type: -

Identifier Source: org_study_id

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