A study of Methylphenidate and Pharmacogenomic Calibration
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-000777
Sponsor Protocol Number: 18-000777
About this study
The purpose of this study is to evaluate the predictive value of a custom designed SNP panel test on overall side effect burden caused by methylphenidate at week 8, as well as treatment response. The measure of overall side effect burden will take into account both the number and severity of side effects.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 6-17 years of age.
- Diagnosed with ADHD (any type) based on clinical diagnosis, Vanderbilt ADHD Diagnostic Parent and Teacher13 scores greater than 6, and the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)14.
- Starting new stimulant class medication for ADHD.
- Able to take oral medication.
- Willing to adhere to the study protocol.
- Provide a signed and dated informed consent form (parents) and assent (subjects).
- Stated willingness to comply with all study procedures and availability for the duration of the study.
Exclusion Criteria:
- History of substance use disorders (including nicotine).
- Known intellectual disability (full scale IQ < 70).
- Unstable or untreated medical illnesses.
- Family history of sudden cardiac death (prior to age 45) or personal history of cardiomyopathy or arrhythmia.
- Lifetime history of eating disorders or schizophrenic spectrum disorders
- Known allergic reactions to components
- Female patients who are pregnant
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Jyoti Bhagia, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available