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:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT01533493
Eligibility Criteria:
Inclusion Criteria:
1. Male or female adults ages 18-50 years
2. A diagnosis of childhood onset ADHD, according to the Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition (DSM-IV) based on clinical assessment
3. A score of 20 or more on the Adult ADHD Investigator Symptom Report Scale (AISRS)
4. EFDs as established by at least 2 abnormal (\>65) subscales of BRIEF-A
Exclusion Criteria:
1. A history of non-response or intolerance to methylphenidate at adequate doses as determined by the clinician
2. A history of non-response or intolerance to memantine at adequate doses as determined by the clinician
3. Pregnant or nursing females
4. A history of clinically unstable or significant other psychiatric conditions including suicidality, homicidality, bipolar disorder, psychosis, or current tic disorder, as judged by the clinician
5. History of narrow angle glaucoma
6. Current (within 3 months) DSM-IV criteria for substance abuse or dependence
7. Medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including cardiovascular disease, hypertension, history of renal or hepatic impairment, organic brain disorders, or history of seizure disorder.
8. Abnormal hematological or metabolic parameters
9. IQ \< 80
10. Current use of any psychotropic medication
11. Lack of facility with the English language
12. Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01533493
Study Brief:
Protocol Section:
NCT01533493