Anorexia NervosaNCT05862389
Study on the Mechanism of Eating Disorder
An observational study of Anorexia Nervosa and Bulimia Nervosa, run by Peking University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 13 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Bulimia Nervosa
- How many people
- 750 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: patients who are diagnosed with anorexia nervosa and bulimia nervosa.
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Mental Health, Peking University Sixth Hospital
Beijing
Tianmei Si, PhD., MD., 861062723748, sitianmei@bjmu.edu.cn
Tianmei Si, PhD., MD
About this study
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.
- Conditions
- Anorexia Nervosa, Bulimia Nervosa
- Keywords
- Eating disorder, anorexia nervosa, bulimia nervosa, functional magnetic resonance imaging, EEG
- Medical subject headings
- Anorexia Nervosa, Bulimia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anorexia nervosa | Patients with anorexia nervosa. | |
| Bulimia nervosa | Patients with bulimia nervosa. | |
| Healthy control | The healthy control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 0 to Day 56
Secondary outcomes (2)
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
Measured: 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
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.
Measured: Day 0 to Day 28; Day 0 to Month 3; Day 0 to Month 6; Day 0 to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start1 Sep 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tian-Mei Si, Ph.D, Study director, Peking University Sixth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862389
- Sponsor's protocol ID
- 2022-1-19-3
- Status last verified
- May 2023
- First submitted
- 23 Apr 2023
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Mechanism of Eating Disorder
- ClinicalTrials.gov ID
- NCT05862389
- Acronym / sponsor ID
- 2022-1-19-3
- Conditions
- Anorexia Nervosa, Bulimia Nervosa
- Keywords
- Eating disorder, anorexia nervosa, bulimia nervosa, functional magnetic resonance imaging, EEG
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anorexia nervosa | – | –Patients with anorexia nervosa. |
| Bulimia nervosa | – | –Patients with bulimia nervosa. |
| Healthy control | – | –The healthy control group |
Who may qualify
- Ages
- 13 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- patients who are diagnosed with anorexia nervosa and bulimia nervosa.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tian-Mei Si, Ph.D study director
Peking University Sixth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa and Bulimia Nervosa, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tian-Mei Si, Ph.D (861062723748, sitianmei@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of severity of illness at 8 weeks (time frame: Day 0 to Day 56). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.