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Study on the Mechanism of Eating Disorder

Study on the Mechanism of Eating Disorder

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05862389
Enrollment
750
Registered
2023-05-17
Start date
2022-09-01
Completion date
2030-12-31
Last updated
2023-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia Nervosa, Bulimia Nervosa

Keywords

Eating disorder, anorexia nervosa, bulimia nervosa, functional magnetic resonance imaging, EEG

Brief 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.

Interventions

None listed

Sponsors

Peking University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
13 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

Anorexia nervosa 1. Anorexia nervosa according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5); 2. Age: 13-35 (including 13 and 35) 3. BMI: 13-17.5kg/m\^2 4. 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. 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

1. Patients who meet DSM-5 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 contraindications; 6. Patients who are regarded as unsuitable by investigators for this clinical trial.

Design outcomes

Primary

MeasureTime frameDescription
The change of severity of illness at 8 weeksDay 0 to Day 56The 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.
The change of eating disorder behaviors and cognitionDay 0 to Day 56The 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.

Secondary

MeasureTime frameDescription
The change of severity of illness at early or later timepoints during treatmentDay 0 to Day 28; Day 0 to Month 3; Day 0 to Month 6; Day 0 to Month 12The 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
The change of eating disorder behaviors and cognitionDay 0 to Day 28; Day 0 to Month 3; Day 0 to Month 6; Day 0 to Month 12The 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.

Countries

China

Contacts

Primary ContactTian-Mei Si, Ph.D
sitianmei@bjmu.edu.cn861062723748

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026