Anorexia Nervosa Eating disorders, Anorexia nervosa
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Eligible patients must meet all of the following criteria: 1) Outpatients diagnosed with anorexia nervosa (AN) based on the diagnostic criteria of the DSM-5-TR. 2) Male or female patients aged between 16 and 65 years at the time of obtaining consent. 3) Patients with a BMI between 14.0 kg/m2 and 18.5 kg/m2 (inclusive). 4) Patients who have received sufficient explanation regarding the study, fully understood the content, and have voluntarily provided written informed consent to participate. (For patients aged 17 years or younger, both the patient and their legal representative must provide consent.) 5) Patients who are able to attend outpatient visits once per week.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded: 1) Patients with serious physical complications or those requiring hospitalization for the treatment of physical symptoms. 2) Patients who require treatment for serious physical illnesses (e.g., diabetes). 3) Patients with imminent suicidal ideation or severe psychiatric symptoms. 4) Patients with comorbid substance dependence or alcohol dependence. 5) Patients with intellectual disability or learning disorders that make it difficult to understand the assessments and treatment procedures. 6) Patients with insufficient understanding of the Japanese language, making it difficult to comprehend the assessments and treatment procedures. 7) Pregnant patients. 8) Any other patients deemed inappropriate for safe participation in this study by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body mass index (BMI, kg/m2) between Week 26 and Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome Measures 1) Symptom assessment scales using self-administered questionnaires 1. Autism Spectrum Quotient (AQ) 2. Adult ADHD Self-Report Scale (ASRS) 3. Japanese Adult Reading Test (JART) 3) Symptom assessment by structured clinical interview 1. Change in Clinical Global Impression-Severity/Change (CGI-S/C) score 2. Change in Modified Global Assessment of Functioning Scale-Short Form (mGAF-SF) score 4) Change in cognitive function test scores (ROCFT, CANTAB) 5) Dropout rate 6) Remission rate 7) Brain imaging assessments (resting-state functional MRI, structural MRI,T1-weighted, T2-weighted, DTI) | — |
Contacts
Chiba University