SPN-812 for ADHD

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Supernus Pharmaceuticals, Inc.

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?Open label, flexible dose, decentralized clinical trial evaluating the efficacy and safety of SPN-812 in adults with ADHD and mood symptoms.

Eligibility Criteria

Adults over 18 with ADHD and mood symptoms, who can sign consent and use the study app for telemedicine appointments. Women must not be pregnant or nursing and agree to birth control if of childbearing potential; men should agree to contraception too. Excludes recent substance abusers, those on certain medications, or with severe mental health issues.

Inclusion Criteria

Has a CGI-S score ≥3 at Screening

Has an AISRS Total score ≥24 at Screening

I am willing and able to give my consent electronically.

+11 more

Exclusion Criteria

I am pregnant, nursing, or not using birth control while sexually active with a male partner.

I have had a serious head injury or neurological condition that may affect my brain function.

Has any history of schizophrenia, schizoaffective disorder, or bipolar disorder, or has any other psychiatric disorders in the investigator's clinical judgement would interfere with their ability to participate in the study

+9 more

Participant Groups

The trial is testing SPN-812 (Qelbree®) in adults with ADHD and mood symptoms. It's an open-label study where everyone gets the drug at flexible doses to see how effective and safe it is when participants manage their own treatment using a mobile app.

1Treatment groups

Experimental Treatment

Group I: Open-Label TreatmentExperimental Treatment1 Intervention

SPN-812 (200mg to 600mg once daily) for up to 14 weeks

SPN-812 is already approved in United States for the following indications:

🇺🇸 Approved in United States as Qelbree for: