ADHD Study for Children and Teens

Intuniv vs Strattera vs Placebo

Study Specific Details:

Intuniv vs Placebo- this is a a randomized, double-blind, parallel-group, placebo- and active comparator-controlled,3 treatment arm study. Dr. Handal will be able to find our medication the subject is on in case of emergency.
Entire study is about 4 mo. (18 total visits) with 7 weekly visits then every 3-4 weeks. Option to enroll in a 12 month open label extension.
Participants are reimbursed $50 for their time and travel at the end of each completed visit.

Male or Female ages 6-17.
Must meet DSM-5 criteria for a primary diagnosis of ADHD based on a psychiatric evaluation using the K-SADS-PL.
The protocol allows enrolling of subjects for whom stimulant therapy OR who are drug/stimulant naive providing that the stimulant are considered unsuitable for the subject based on physician's/ investigators judgement. This may include risk of abuse due to personal or family history of substance use order, low weight, cardiovascular disorders, etc. ***Reasons such as affordability, parents refuse is not considered valid ones and will not classify the patient as unsuitable for the stimulant treatment.
Children aged 6-12 with a body weight of 55lbs or more or aged 13-17 with a body weight of 75lbs or more and BMI less than the 95th percentile are eligible.
Subject is functioning at an age appropriate level intellectually.
Must be able to swallow a pill.

Subject has a current controlled (requiring medication or therapy) or uncontrolled comorbid psychiatric disorder EXCEPT ODD to include an comorbid Axis I and Axis II disorders based on the K-SADS.
Family history of Tourette's disorder, sudden cardiac death, or ventricular arrhythmia.
Family history in either biological parent of bipolar disorder or psychosis,
Subject has a history of seizure disorder except for a single childhood febrile seizures that occurred prior to age 3.
Subject has been physically, sexually, and/or emotionally abused.
Subject has substance use disorder or has been suspected of such (except nicotine) within the past 6 month.
History or presence of suicidal ideation or significant self-injurious behavior.

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