NCT04839562

A Controlled Study of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD) in Adults

Solriamfetol for ADHD in Adults: A Double-Blind Placebo Controlled Pilot Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A double-blind, placebo controlled study of solriamfetol for adults age 18 to 65 with diagnosis of Attention Deficit Hyperactivity Disorder.

Detailed description

Subjects will be between 18 and 65 years old, have at least 5 current symptoms of inattentive or impulsive-hyperactive traits, and childhood onset of ADHD symptoms, defined as two symptoms of inattentive or of impulsive/hyperactive traits by the age of 12. Subjects will also have a score of 20 or more on the Adult ADHD Investigator Symptom Report Scale (AISRS). The investigators will exclude individuals who are contraindicated by current FDA label recommendations, which elaborates appropriate use of solriamfetol for individuals with sleep apnea and narcolepsy. This will be a a six week, double blind, dose-optimization study. After giving informed consent to participate, participants will undergo a comprehensive assessment including a psychiatric assessment reviewing eligibility.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Solriamfetol 75 MG	Daily oral consumption
DRUG	Solriamfetol 150 MG	Daily oral consumption
OTHER	Placebo	Placebo

Timeline

• Start date: 2021-08-06
• Primary completion: 2023-01-27
• Completion: 2023-01-27
• First posted: 2021-04-09
• Last updated: 2024-03-04
• Results posted: 2024-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study