Study on the Mechanism of Eating Disorder

Sponsor

Peking University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05862389

Collaborator

(none)

750

Enrollment

Location

Anticipated Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Nervosa Bulimia Nervosa

Study Design

Study Type:

Observational

Anticipated Enrollment :

750 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Study on the Mechanism of Eating Disorder

Actual Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2027

Anticipated Study Completion Date :

Dec 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Anorexia nervosa Patients with anorexia nervosa.
Bulimia nervosa Patients with bulimia nervosa.
Healthy control The healthy control group

Outcome Measures

Primary Outcome Measures

The change of severity of illness at 8 weeks [Day 0 to Day 56]
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.
The change of eating disorder behaviors and cognition [Day 0 to Day 56]
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.

Secondary Outcome Measures

The change of severity of illness at early or later timepoints during treatment [Day 0 to Day 28; Day 0 to Month 3; Day 0 to Month 6; Day 0 to Month 12]
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
The change of eating disorder behaviors and cognition [Day 0 to Day 28; Day 0 to Month 3; Day 0 to Month 6; Day 0 to Month 12]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Anorexia nervosa

Anorexia nervosa according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5);
Age: 13-35 (including 13 and 35)
BMI: 13-17.5kg/m^2
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.
Do not take any psychiatric medications in past one month.

Bulimia nervosa

Bulimia nervosa according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5);
Age: 13-35 years old (including 13 and 35)
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.
Do not take any psychiatric medications in past one month.

Exclusion Criteria:

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;
Patients who receive repetitive Transcranial Magnetic Stimulation (rTMS) or modified electroconvulsive therapy (MECT) treatment in past six months.
Patients with severe suicidal tendencies or suicidal behavior
Pregnant or lactating women;
Patients with MRI contraindications;
Patients who are regarded as unsuitable by investigators for this clinical trial.