PK/PD Pediatric ADHD Classroom Study

• Status: Completed
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the association between blood drug levels and the corresponding scores of commonly used behavioral instruments based upon data collected following administration of three different methylphenidate hydrochloride extended-release drug products in children with ADHD.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Center for Psychiatry And Behavioral Medicine Inc.; Food and Drug Administration (FDA)
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

1. Male and female outpatients

2. Ages 6-12 years at time of screening

3. Judged by the investigator to be physically healthy and suitable for participation in the study

4. Diagnosis of DSM-5ADHD combined, predominantly inattentive or hyperactive/impulsive presentation, per clinical evaluation and confirmed by the MINI-KID

5. Clinical Global Impressions-Severity (CGI-S) ≥ 3

6. ≥ 90th percentile normative value for gender and age on the ADHD RS-IV total score at screening or baseline

7. Study participant has a parent/legal guardian who is willing and able to give written informed consent for him/her to participate in the study

8. Study participant must be able to give assent to participate in the trial

9. Study participant and legal guardian must be able to speak and understand English

10. Able to tolerate multiple finger pricks

11. Willing to comply with all study procedures

Exclusion Criteria:

1. Current (last month) psychiatric diagnosis other than specific phobia, motor skills disorders, oppositional defiant disorder, sleep disorders, elimination disorders, adjustment disorders, learning disorders, or communication disorders. Participants with school phobia or separation anxiety will not be eligible

2. Cognitively impaired, in the investigator's opinion

3. Any clinically significant chronic medical condition that, in the judgment of the investigator, may interfere with the participant's ability to participate in the study

4. Seizure disorder excluding a history of febrile seizures

5. Thyroid disease

6. Tourette's disorder or chronic tic disorder (mild medication induced tics are allowed)

7. Serious cardiac condition including cardiomyopathy, serious arrhythmias, structural cardiac disorders, or severe hypertension

8. Glaucoma

9. Current or recent (within the past 6 months) DSM-5 drug dependence or substance abuse (excluding nicotine and caffeine)

10. Pregnant or nursing females. Females must have a negative urine pregnancy test at screening as well as four additional visits and must be abstinent or use adequate and reliable contraception throughout the study

11. Currently treated and satisfied with ADHD medication

12. Current psychotropic medications other than sedative hypnotics for sleep

13. Use of atomoxetine, clonidine, guanfacine or a monoamine oxidase inhibitor within 28 days of the baseline visit

14. Participation in another investigational medication study within 30 days prior to screening

15. Clinically significant abnormal laboratory result, electrocardiogram (ECG) result, physical examination, or vital signs at screening that the investigator considers to be inappropriate to allow participation in the study

16. Planned use of prohibited drugs from the baseline visit through the end of the trial

17. History of allergic reaction or a known or suspected sensitivity to any substance that is contained in the study drugs

18. Food allergies that are determined by the PI as too severe to be easily accommodated for during the study

19. Inability to swallow study medication