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 @ 2:05 PM
Ignite Modification Date:
2025-12-24 @ 2:05 PM
NCT ID:
NCT03009695
Eligibility Criteria:
Inclusion Criteria:
1. Age: 22-65 years
2. If the patient is taking medications, it must take on a stable dose for at least a month
3. Obesity: ≤ 30 BMI ≤ 45
4. Ability to follow verbal or written instructions.
Exclusion Criteria:
1. Axis-I and II psychiatric disorders according to DSM criteria 5 (such as Major Depression, Bipolar Disorder, or Attention Deficit Disorder)
2. IQ score \< 85
3. Organic brain disorders: history of stroke, brain major surgery or head trauma
4. Pregnancy or lactation, absence of medically approved contraceptive methods in females of childbearing potential
5. Serious or poorly controlled diseases (hepatic, renal or hearth failure, atrial fibrillation or other heart rhythm disorders)
6. H yperglycemia - Fasting glucose level \> 170 mg/dl
7. Urine drug screen positive for amphetamines, barbiturates, cannabinoids, cocaine metabolites, opiates and phencyclidine
8. Positivity to blood alcohol test
9. Metal in any part of the head, except for dental fillings
10. Implanted infusion pumps
11. Intracardiac devices (pacemakers, heart valves ...)
12. History of diseases whose exacerbation could be fatal (e.g. cardiovascular disease, increased intracranial pressure)
13. History of epilepsy or a family history of epilepsy among first-degree relatives
14. Medications associated with lowered seizure threshold (such as antidepressants, anxiolytics…)
15. Treatment with anti-obesity medications or other medications influencing body weight within 3 month prior to Screening Visit
16. Starting a weight loss plan at any time during data collection for the subject
17. Patients affected by galactosemia, priapism and terminal illness
18. Patients on fluid restriction for SIADH or other conditions
19. Contraindications to perform the Magnetic Resonance Imaging (MRI).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
65 Years
Study:
NCT03009695
Study Brief:
Protocol Section:
NCT03009695