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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT01673594
Eligibility Criteria:
Inclusion
1. Male and female outpatients
2. age 18-30
3. diagnosis of ADHD by DSM-IV, per clinical evaluation and confirmed by structured interview
4. likeability response (\> 5) on Question #2 of the DRQ-S after an initial test dose of 60 mg of IR MPH.
5. Baseline ADHD severity of \> 20 on the Adult ADHD Investigator System Report Scale (AISRS)
6. Able to participate in blood draws and to swallow pills.
7. Subjects must be considered reliable reporters, must understand the nature of the study and must sign an informed consent document
Exclusion
1. Any current (last month), non-ADHD Axis I psychiatric conditions
2. Ham-D \> 16, BDI \> 19, or Ham-A \> 21
3. Any clinically significant chronic medical condition
4. any cardiovascular disease or hypertension
5. Clinically significant abnormal baseline laboratory values
6. I.Q. \< 80)
7. Organic brain disorders
8. Seizures or tics
9. Pregnant or nursing females
10. Clinically unstable psychiatric conditions (i.e. suicidal behaviors, psychosis)
11. Current or recent (within the past year) substance abuse/dependence
12. patients on other psychotropics
13. Current or prior adequate treatment with MPH
14. known hypersensitivity to methylphenidate
15. Current opioid use (by history and urine screen) or potential need for opioid analgesics during the study
16. acute hepatitis or liver failure (baseline blood tests).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT01673594
Study Brief:
Protocol Section:
NCT01673594