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RecruitingNCT05862389Updated May 24, 2023

Study on the Mechanism of Eating Disorder

An observational study in Anorexia Nervosa and Bulimia Nervosa, sponsored by Peking University. Recruiting at 1 site in China. Open to participants aged 13 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-24.

Sponsored by Peking University · Observational

From the registry’s dates

  • Started Sep 2022; still recruiting 4 years 2 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
750
Ages
13 Years to 35 Years
Sex
All
01

Study summary

Eating disorders (EDs) are severe chronic psychiatric disorders with a not fully understood etiopathogenesis. Previous studies have revealed some biological mechanisms of EDs. However, the etiology and maintenance mechanism of EDs, especially the neuro-mechanisms is still unknown. To explore the pathogenic mechanism and treatment biomarkers of EDs, we design this study. the multidimensional data including the clinicopathological features, neuroimaging data (functional and structural magnetic resonance imaging), electroencephalogram and inflammatory cytokines will be used to investigate the biomarkers for diagnosis and treatment effectiveness.

02

Conditions studied

  • Anorexia Nervosa
  • Bulimia Nervosa

Keywords

  • Eating disorder
  • anorexia nervosa
  • bulimia nervosa
  • functional magnetic resonance imaging
  • EEG
03

In context

Anorexia Nervosa

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

This study's planned enrollment of 750 is above the median of 78 across 142 observational studies indexed under Anorexia Nervosa.

Browse Anorexia Nervosa studies →

Lead sponsor

Peking University is the lead sponsor of 419 studies on the registry; 123 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

patients who are diagnosed with anorexia nervosa and bulimia nervosa.

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

Anorexia nervosa

  1. Anorexia nervosa according to (5th edition) (DSM-5);
  2. Age: 13-35 (including 13 and 35)
  3. : 13-17.5kg/m\^2
  4. The participants and/or their legal guardians ( for participants who are younger than 18-year-old) sign the form voluntarily and agree to participate in all visits and examinations as required by the trial protocol.
  5. Do not take any psychiatric medications in past one month.

Bulimia nervosa

  1. Bulimia nervosa according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5);
  2. Age: 13-35 years old (including 13 and 35)
  3. The participants and/or their legal guardians ( for participants who are younger than 18-year-old) sign the informed consent form voluntarily and agree to participate in all visits and examinations as required by the trial protocol.
  4. Do not take any psychiatric medications in past one month.

Exclusion criteria

Exclusion Criteria:

  1. Patients who meet diagnostic criteria for other mental disorders: Major depressive disorder, anxiety, obsessive-compulsive disorder, personality disorder, mental retardation; drug and/or alcohol dependence;
  2. Patients who receive repetitive Transcranial Magnetic Stimulation (rTMS) or modified electroconvulsive therapy (MECT) treatment in past six months.
  3. Patients with severe suicidal tendencies or suicidal behavior
  4. Pregnant or lactating women;
  5. Patients with MRI ;
  6. Patients who are regarded as unsuitable by investigators for this clinical trial.
Terms in these criteria, in plain language(4)

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.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
750 participants (estimated)
Patient registry
No

Groups and cohorts

  • Anorexia nervosa

    Patients with anorexia nervosa.

  • Bulimia nervosa

    Patients with bulimia nervosa.

  • Healthy control

    The healthy control group

06

What researchers measure

Primary outcomes

  1. The change of severity of illness at 8 weeks

    The change of scores of Eating disorder Inventory (EDI) will be used to estimate the change of severity of illness. The scores of 8-week will be compared with those of baseline. The maximum of EDI is 396 and the minimum score is 0.

    Time frame: Day 0 to Day 56

  2. The change of eating disorder behaviors and cognition

    The change of scores of Eating Disorder Examination Questionnaire (EDEQ) will be used to estimate the change of behaviors and cognition during treatment.The maximum score of EDEQ is 32.5 and the minium score is 0.

    Time frame: Day 0 to Day 56

Secondary outcomes

  1. The change of severity of illness at early or later timepoints during treatment

    The change of scores of Eating disorder Inventory (EDI) will be used to estimate the change of severity of illness. The maximum of EDI is 396 and the minimum score is 0

    Time frame: Day 0 to Day 28; Day 0 to Month 3; Day 0 to Month 6; Day 0 to Month 12

  2. The change of eating disorder behaviors and cognition

    The change of scores of Eating Disorder Examination Questionnaire (EDEQ) will be used to estimate the change of behaviors and cognition during treatment.The maximum score of EDEQ is 32.5 and the minium score is 0.

    Time frame: Day 0 to Day 28; Day 0 to Month 3; Day 0 to Month 6; Day 0 to Month 12

07

Study locations

1 of 1 sites recruiting
08

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 Sep 2022 (actual). Primary completion is estimated for Dec 2027, 63 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 63 months is above 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
Apr 23, 2023
First posted
May 17, 2023
StartActual
Sep 1, 2022
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2030
Last update
May 24, 2023
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 May 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05862389
Lead sponsor
Peking University
Responsible party
Sponsor
First posted
May 17, 2023
Start date
Sep 1, 2022
Primary completion
Dec 2027 (estimated)
Completion
Dec 2030 (estimated)
Last update
May 24, 2023

Study contacts

Tian-Mei Si, Ph.D
Contact
sitianmei@bjmu.edu.cn
861062723748
Tian-Mei Si, Ph.D
study director · Peking University Sixth Hospital

Oversight

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

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