Study on the Mechanism of Eating Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Anorexia Nervosa, Bulimia Nervosa. Basic parameters: 13 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- The change of severity of illness at 8 weeks [Time frame: Day 0 to Day 56]
- The change of eating disorder behaviors and cognition [Time frame: Day 0 to Day 56]
Secondary outcome measures (2)
- The change of severity of illness at early or later timepoints during treatment [Time frame: 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 [Time frame: Day 0 to Day 28; Day 0 to Month 3; Day 0 to Month 6; Day 0 to Month 12]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Institute of Mental Health, Peking University Sixth Hospital — Beijing
Identifiers
NCT: NCT05862389 · 2022-1-19-3