Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT02263404
Eligibility Criteria:
Inclusion Criteria:
1. Female or male patients aged 20-60 years.
2. Diagnosis of anorexia nervosa, restricting or binge-purging subtype, as defi ned in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR).
3. Chronicity or treatment resistance shown by some or all of:
* A pattern of 3 years' duration of relentless unresponsiveness to repeated voluntary hospital admissions, characterised by failure to complete treatment or immediate weight relapse after treatment.
* A pattern of increasing medical instability, accompanied by refusal to participate in or a pattern of poor response to intensive expert treatment and increasing medical acuity, lasting at least 2 years and including at least two episodes of involuntary feeding.
* A pattern of chronic stable anorexia nervosa that has lasted at least 10 years.
* Able to provide informed consent.
4. Able to comply with all testing, follow-ups, and study appointments and protocols.
Exclusion Criteria:
1. Person with consciousness disorder on opioid abstinence, seriously aggressive, heavily dehydrated and intending to commit suicide.
2. Patients with serious liver and kidney dysfunction, pulmonary decompensation, or complicated with serious damage in other systems.
3. Patients with serious infectious disease.
4. Patients with history of serious neurological or psychiatrical diseases.
5. Person with history of HIV infection or serious malnutrition.
6. Dependent upon and addicted to multiple drugs.
7. Any contraindication to MRI or PET scanning.
8. Body-mass index less than 13.
9. Attended some other trials within one year.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT02263404
Study Brief:
Protocol Section:
NCT02263404