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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT01868204
Eligibility Criteria:
Inclusion Criteria:
1. Patients of Eating Disorders Clinic with a diagnosis of Bulimia Nervosa, Eating Disorders Not Otherwise Specified 3 and 6 with Binge Eating Disorder according to research criteria in Diagnostic and Statistical of Mental Disorders, version IV revised, who started taking Topiramate.
2. Probands with diagnosis of obesity (BMI ≥30 kg/m2- 40 kg/m2).
3. Capable to give written informed consent.
4. Age of 18 to 50 years at screening.
5. Maternal and paternal grandparents of Mexican descent.
6. Probands without psychopharmacological treatment (including anticonvulsants) at least 4 weeks before inclusion.
Exclusion Criteria:
1. Subjects with alcohol or substance abuse or dependence.
2. Any psychiatric or medical disorder that requires inpatient treatment.
3. Psychosis or suicidal thoughts.
4. Abnormal blood chemistry.
5. Diabetes uncontrolled.
6. Unstable hypertension or difficult to control (criterion 7 of inclusion section).
7. Metabolic acidosis.
8. Narrow-angle glaucoma.
9. Unstable hypothyroidism or hyperthyroidism.
10. Unable or unwilling to give a blood sample.
11. Pace-makers or metal implants that would preclude the functional Magnetic Resonance Image scan.
12. Pregnant or lactating women at screening or positive blood pregnancy test.
13. Presence of any epileptic disorder.
14. Subjects unable or unlikely to follow the protocol procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01868204
Study Brief:
Protocol Section:
NCT01868204