A Controlled Study of Solriamfetol for ADHD in Adults
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- "Attention Deficit Hyperactivity Disorder"
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
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 mo...
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.
Tracking Information
- NCT #
- NCT04839562
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Craig Surman, MD Mass General Brigham
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