Study on the Mechanism of Eating Disorder

Anorexia Nervosa Clinical Trial

Official title:

Study on the Mechanism of Eating Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05862389
• Other study ID #: 2022-1-19-3
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: December 2030

Study information

• Verified date: May 2023
• Source: Peking University
• Contact: Tian-Mei Si, Ph.D
• Phone: 861062723748
• Email: sitianmei[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: December 2030
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Bulimia
• Bulimia Nervosa
• Feeding and Eating Disorders

Locations

Country	Name	City	State
China	Institute of Mental Health, Peking University Sixth Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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