Study on the Mechanism of Eating Disorder

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.

Study Overview

• Status: Recruiting
• Conditions: Anorexia Nervosa; Bulimia Nervosa

• Study Type: Observational
• Enrollment (Anticipated): 750

Contacts and Locations

• Study Contact: Name: Tian-Mei Si, Ph.D; Phone Number: 861062723748; Email: sitianmei@bjmu.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Institute of Mental Health, Peking University Sixth Hospital
    • Contact: Tianmei Si, PhD., MD.; Phone Number: 861062723748; Email: sitianmei@bjmu.edu.cn
    • Principal Investigator: Tianmei Si, PhD., MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

patients who are diagnosed with anorexia nervosa and bulimia nervosa.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Anorexia nervosa; Patients with anorexia nervosa.
Bulimia nervosa; Patients with bulimia nervosa.
Healthy control; The healthy control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0 to Day 56
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.	Day 0 to Day 56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 0 to Day 28; Day 0 to Month 3; Day 0 to Month 6; Day 0 to Month 12
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.	Day 0 to Day 28; Day 0 to Month 3; Day 0 to Month 6; Day 0 to Month 12

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Study Director: Tian-Mei Si, Ph.D, Peking University Sixth Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): December 1, 2027
• Study Completion (Anticipated): December 1, 2030

Study Registration Dates

• First Submitted: April 23, 2023
• First Submitted That Met QC Criteria: May 7, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: functional magnetic resonance imaging; EEG; anorexia nervosa; Eating disorder; bulimia nervosa
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Anorexia; Anorexia Nervosa; Bulimia; Feeding and Eating Disorders; Bulimia Nervosa
• Other Study ID Numbers: 2022-1-19-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No