NCT05862389

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
54mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Sep 2022Dec 2030

Study Start

First participant enrolled

September 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

5.3 years

First QC Date

April 23, 2023

Last Update Submit

May 22, 2023

Conditions

Anorexia NervosaBulimia Nervosa

Keywords

Eating disorderanorexia nervosabulimia nervosafunctional magnetic resonance imagingEEG

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • 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 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

Study Arms (3)

Anorexia nervosa

Patients with anorexia nervosa.

Bulimia nervosa

Patients with bulimia nervosa.

Healthy control

The healthy control group

Eligibility Criteria

Age13 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients who are diagnosed with anorexia nervosa and bulimia nervosa.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Mental Health, Peking University Sixth Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Anorexia NervosaBulimia NervosaFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tian-Mei Si, Ph.D

    Peking University Sixth Hospital

    STUDY DIRECTOR

Central Study Contacts

Tian-Mei Si, Ph.D

CONTACT

861062723748sitianmei@bjmu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2023

First Posted

May 17, 2023

Study Start

September 1, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2030

Last Updated

May 24, 2023

Record last verified: 2023-05

Locations

CN(1)