ADHD Study for Children – Stimulant

Jornay vs Placebo

Study Specific Details:

Jornay vs Placebo – this is a a randomized, double-blind, parallel-group, placebo-controlled study. Dr. Handal will be able to find out medication the subject is on in case of emergency.
Entire study is about 2 months (6 total visits) with 4 weekly visits and an end of study visit.
Participants are reimbursed $85 for their time and travel at the end of each completed visit.

Male or Female ages 4-5.
Must meet DSM-5 criteria for a primary diagnosis of ADHD based on a psychiatric evaluation using the MINI-KID.
Height and weight must be between the 5th and 95th percentile for age and gender.
Must have undergone an adequate course of nonpharmacologic treatment or has a severe enough condition in the opinion of the investigator to consider enrollment prior to nonpharmacologic treatment.
Initiation of Cognitive Behavioral Therapy within 30 days prior to baseline.
Oppositional defiant disorder (ODD) is allowed as long as it is not the primary focus of treatment.
Mood disorder is at the discretion of the PI.

Any diagnosis of psychosis, bipolar, major depressive disorder, anxiety disorder, eating disorder, conduct disorder, or OCD
History of psychosis, autism, tic disorder, disruptive mood dysregulation disorder, intellectual disability, Tourette's Syndrome, confirmed genetic disorder with cognitive and/or behavioral disturbances.
History of seizure disorder (except febrile seizures prior to age 4 and with the last occurrence at least 1 year prior to study participation).
Patient is considered to be at risk of suicide.

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