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 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT00302393
Eligibility Criteria:
Inclusion Criteria:
1. Signed written informed consent to participate in the study
2. Age: 18 - 55
3. If female, non-pregnant, non-nursing, using an adequate form of birth control or a negative plasma pregnancy test
4. Supine and standing blood pressure within the range 110/60 to 150/90 mmHg
5. Heart rate, after resting for 5 minutes, within the range 46-90 beats/min
6. Subjects who are within 20% of the ideal weight for height
7. Right handed
Exclusion Criteria:
1. Subjects with marked anxiety, tension, and agitation since the drug may aggravate these symptoms
2. Subjects with known hypersensitivity to methylphenidate or other components of Concerta or Ritalin
3. Subjects with glaucoma
4. Subjects with motor tics or with a family history or diagnosis of Tourette's syndrome
5. Subjects treated with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuation of treatment with MAOIs
6. Diagnosis of any psychotic disorder, bipolar disorder, severe depression, severe anxiety, or autism. Subjects with mild mood, oppositional, conduct, and anxiety disorders may be permitted to participate if considered appropriate by the investigator.
7. Scores of Baseline Scales:
* Hamilton Depression Scale \> 17 (out of a possible 67 on the 21-item scale) (Hamilton 1960)
* Beck Depression Inventory \> 19 (out of a possible 63 on the 21-item scale) (Beck et al 1961)
* Hamilton Anxiety Scale \> 21 (out of a possible 56 on the 14-item scale) (Hamilton 1959)
8. Diagnosis of ADHD (attention deficit hyperactivity disorder)
9. History of head trauma with loss of consciousness, organic brain disorders, seizures, or neurosurgical intervention
10. Any clinically significant chronic medical condition, in the judgment of the investigator
11. Mental impairment as evidenced by an intelligence quotient (I.Q.) \< 75
12. Exposure to dopamine receptor antagonists within the previous three (3) months
13. Exposure to radiopharmaceuticals within four (4) weeks prior to PET scan
14. Subjects receiving psychotropic medication
15. Any clinically significant abnormality in the screening laboratory tests, vital signs, or 12-lead ECG (electrocardiogram), outside of normal limits
16. Any woman of childbearing potential who is seeking to become pregnant or suspects that she may be pregnant
17. Subjects with a known recent history (within the past six \[6\] months) of illicit drug or alcohol dependence
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00302393
Study Brief:
Protocol Section:
NCT00302393