Study on the Mechanism of Eating Disorder

NCT ID: NCT05862389

Last Updated: 2023-05-24

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

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2030-12-31

Brief Summary

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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.

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_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Anorexia nervosa

Patients with anorexia nervosa.

No interventions assigned to this group

Bulimia nervosa

Patients with bulimia nervosa.

No interventions assigned to this group

Healthy control

The healthy control group

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tian-Mei Si, Ph.D

Role: STUDY_DIRECTOR

Peking University Sixth Hospital

Locations

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Institute of Mental Health, Peking University Sixth Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tian-Mei Si, Ph.D

Role: CONTACT

861062723748

Facility Contacts

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Tianmei Si, PhD., MD.

Role: primary

861062723748

Other Identifiers

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2022-1-19-3

Identifier Type: -

Identifier Source: org_study_id

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