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NCT Number: NCT05862389

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.

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Key information

Conditions

Anorexia Nervosa Bulimia Nervosa Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

13 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Mental Health, Peking University Sixth Hospital

Beijing, China

Location status: Recruiting

Location contact

Tianmei Si, PhD., MD

PRINCIPAL_INVESTIGATOR

Tianmei Si, PhD., MD.

CONTACT

[email protected]

861062723748

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The change of severity of illness at 8 weeks

    Time frame: 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.

  2. The change of eating disorder behaviors and cognition

    Time frame: 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 outcomes

  1. 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 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

  2. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tian-Mei Si, Ph.D

CONTACT

[email protected]

861062723748

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2030
First posted
May 17, 2023
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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