A Study of Solriamfetol for Adolescents with ADHD

This study is looking at how well and how safely a medication called solriamfetol works for teenagers with Attention-Deficit/Hyperactivity Disorder (ADHD). You might be able to join if you are 12 to 17 years old and have been diagnosed with ADHD. Participants will receive either solriamfetol at one of two different doses, or a placebo (an inactive pill that looks like the study drug). The main goal is to see if solriamfetol can improve ADHD symptoms, measured by a specific rating scale, after 6 weeks. The study plans to enroll 468 participants, but its current status is unclear.

Study design
This is a Phase 3, randomized, double-blind study, meaning participants are randomly assigned to a treatment group and neither you nor your doctor will know which treatment you are receiving. It involves about 468 participants.
What's involved
You would take a capsule once daily for 6 weeks. Your parents or legal guardians would need to give written permission, and you would also need to agree to participate.
Compensation
Not stated in the trial record.
Follow-up
The main assessment for the study is at 6 weeks.

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NCT07717892

A Study to Assess the Efficacy and Safety of Solriamfetol in Adolescents With ADHD

Recruiting
PHASE3Ages 12–17InterventionalTreatment
Axsome Therapeutics, Inc.
~468 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:Solriamfetol Dose ASolriamfetol Dose BPlacebo

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
ADHD-RS-5 Total Score, Change from Baseline to Week 6
Measured over 6 weeks
ADHD
9 sites across 6 states
Florida4
Alabama1
Arkansas1
Kentucky1
Tennessee1
Texas1

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female, aged 12 to \<18 years.
Primary diagnosis of ADHD according to DSM-5 criteria.
Has parents/legal guardians provide written informed consent and has child provide written informed assent to participate in the study before the conduct of any study procedures.

Exclusion

Unable to comply with study procedures.
Medically inappropriate for study participation in the opinion of the investigator.
  • ADHD-RS-5 Total Score, Change from Baseline to Week 66 weeks

    Attention Deficit/ Hyperactivity Disorder Rating Scale-5, Interview with Informant, Adolescent Version (ADHD-RS-5)