NIPH Clinical Trials Search

FNT for Anorexia Nervosa: An Open-Label Study

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Anorexia nervosa
Date of first enrollment	29/05/2026
Target sample size	7
Countries of recruitment
Study type	Interventional
Intervention(s)	aiTBS

Outcome(s)

Primary Outcome

Change in overall psychological symptoms of anorexia nervosa (change from baseline to week 4 in EDI-3 eating disorder risk composite score)

Secondary Outcome

1. Change in overall psychological symptoms of anorexia nervosa (change from baseline to day 5-7, week 2, and 6 in EDI-3 eating disorder risk composite score) 2. Change in ineffectiveness (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 ineffectiveness composite score) 3. Change in interpersonal problems (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 interpersonal problems composite score) 4. Change in affective problems (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 affective problems composite score) 5. Change in overcontrol (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 overcontrol composite score) 6. Change in psychological maladjustment (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 global psychological maladjustment composite score) 7. Change in drive for thinness (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 drive for thinness subscale score) 8. Change in bulimia (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 bulimia subscale score) 9. Change in body dissatisfaction (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 body dissatisfaction subscale score) 10. Change in low self-esteem (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 low self-esteem subscale score) 11. Change in personal alienation (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 personal alienation subscale score) 12. Change in interpersonal insecurity (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 interpersonal insecurity subscale score) 13. Change in interpersonal alienation (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 interpersonal alienation subscale score) 14. Change in interoceptive deficits (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 interoceptive deficits subscale score) 15. Change in emotional dysregulation (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 emotional dysregulation subscale score) 16. Change in perfectionism (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 perfectionism subscale score) 17. Change in asceticism (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 asceticism subscale score) 18. Change in maturity fears (change from baseline to day 5-7, week 2, 4, and 6 in EDI-3 maturity fears subscale score) 19. Change in BMI (change from baseline to day 5-7, week 2, 4, and 6 in BMI) 20. Change in depression symptoms (change from baseline to day 5-7, week 2, 4, and 6 in MADRS total score) 21. Change in anorexia nervosa severity (change from baseline to day 5-7, week 2, 4, and 6 in CGI-S score) 22. Change in treatment efficacy for anorexia nervosa (change from baseline to day 5-7, week 2, 4, and 6 in CGI-I score) 23. Changes in the concentrations of the following brain metabolites (NAA, Glu, Gln, Glx, Cho, mI, GABA) from baseline to week 4 (MRS will be performed at baseline and at week 4) left dorsolateral prefrontal cortex left anterior cingulate cortex 24. Changes in the gut microbiota from baseline to week 4 (16S rRNA gene amplicon sequencing will be performed at baseline and at week 4) 25. All-cause discontinuation 26. Discontinuation due to adverse events 27. Incidence of total adverse events 28. Incidence of serious adverse events 29. Mortality rate 30. Incidences of individual adverse events

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	< 65age old
Gender	Both
Include criteria	1. The clinical trial will be described in detail to the individuals, and written informed consent will be obtained from all participants and their guardians 2. Individuals age: 18 >= years old and < 65 years old 3. Individuals who will meet the DSM-5-TR criteria for anorexia nervosa (restricting type) (based on SCID-5-RV) 4. Individuals with a BMI >= 12 and < 17 5. Individuals who will not respond to at least two antidepressants (>= 10 mg/day in escitalopram equivalents) or antipsychotics (>= 3 mg/day in aripiprazole equivalents) with a sufficient dose for 4 weeks or more (failure to achieve a weight gain of >= 0.5 kg/week during the treatment period). We will confirm the result from their medical records. 6. Individuals who will not respond to inpatient treatment for 4 weeks or more (failure to achieve a weight gain of >= 0.5 kg/week during the treatment period). We will confirm the result from their medical records.
Exclude criteria	1. Individuals with metal implants or devices close to the stimulation site (e.g., cochlear implants, surgical clips with magnetic properties, or neurostimulators such as deep brain stimulation or vagus nerve stimulation), individuals with a cardiac pacemaker 2. Individuals with metal implants or devices not close to the stimulation site (e.g., implanted medication pumps), titanium products in their heads, magnetic dentures/implants 3. Individuals with a history of seizures, a history of intracranial lesions at risk for seizures, individuals taking drugs that reduce seizure threshold (methylphenidate or ketamine), individuals with alcohol or stimulant use disorder or withdrawal, pregnant individuals, individuals with severe physical disease 4. Individuals with a history of receiving rTMS in the current depressive episode (with a diagnosis of major depressive disorder within the past 6 months) 5. Individuals in whom low body weight will be judged to be attributable to psychiatric disorders other than anorexia nervosa (including dementia, depression, bipolar disorder, schizophrenia, obsessive-compulsive disorder, anxiety disorders, autism spectrum disorder, and borderline personality disorder) or to organic diseases (including endocrine and metabolic disorders, gastrointestinal diseases, infections, and malignancies) 6. Individuals with unimproved low body weight due to poor adherence to pharmacological treatment 7. Individuals diagnosed with substance or medication-induced mood disorder 8. Individuals who will answer "yes" at baseline to the following questions: "Do you have any suicidal ideations although you do not have any plans for committing suicide? or "Do you have any suicidal ideations and any plans for committing suicide?" 9. Individuals judged to be inappropriate by researchers