Clinical trial NCT05862389: Study on the Mechanism of Eating Disorder
Official title: Study on the Mechanism of Eating Disorder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anorexia Nervosa
Bulimia Nervosa
Keywords: Eating disorder
anorexia nervosa
bulimia nervosa
functional magnetic resonance imaging
EEG
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 750
Sex: ALL
Minimum age (years): 13
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who are diagnosed with anorexia nervosa and bulimia nervosa.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The change of severity of illness at 8 weeks
timeFrame: Day 0 to Day 56
measure: The change of eating disorder behaviors and cognition
timeFrame: Day 0 to Day 56
Secondary outcomes:
measure: The change of severity of illness at early or later timepoints during treatment
timeFrame: Day 0 to Day 28; Day 0 to Month 3; Day 0 to Month 6; Day 0 to Month 12
measure: The change of eating disorder behaviors and cognition
timeFrame: Day 0 to Day 28; Day 0 to Month 3; Day 0 to Month 6; Day 0 to Month 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Mental Health, Peking University Sixth Hospital
Study officials:
affiliation: Peking University Sixth Hospital
name: Tian-Mei Si, Ph.D
role: STUDY_DIRECTOR
References: