ADHD Study for Children and Teens

Solriamfetol (Sunosi) vs Placebo

Study Specific Details:

Solriamfetol 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 (7 office visits, 2 remote visits) with 6 weekly visits and an end of study visit.
Participants are reimbursed 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 MINI-KID.
ADHD symptoms must be moderate to severe.
Must weigh at least 48.5 lbs, and height and weight must be between the 10th and 95th percentile for age and gender.
Must be able to swallow a capsule with water. Asthma medication is allowed at the discretion of the investigator.
Melatonin (up to 5 mg) is allowed if dose and regimen have been stable for at least 4 weeks prior to baseline.
Cognitive Behavioral Therapy (CBT) for the treatment of ADHD is allowed if following a stable routine for at least 30 days or longer.

Any psychiatric diagnosis other than ADHD.
Has a first-degree relative (biological parent or sibling) with a diagnosis of bipolar I or II, schizophrenia, or schizoaffective disorder.
Has failed 2 or more approved ADHD medications at adequate doses and duration.
History of seizures or seizure-like events; or a history of seizure disorder within the immediate family (siblings, parents).
Any head trauma with loss of consciousness lasting more than 5 min.
History of tic disorder and/or family history of Tourette’s.
Intellectual or severe learning disability.
The patient is considered to be at risk of suicide or has attempted suicide within the past 2 years.
History of substance use disorder within the past 12 months.
Tested positive for Hep B, C, or HIV.

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