Solriamfetol for Depression

(PARADIGM Trial)

Recruiting at 37 trial locations

Overseen By Sunayana Banerjee

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Axsome Therapeutics, Inc.

Disqualifiers: Prior solriamfetol exposure, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

346 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing solriamfetol, a medication that may help improve symptoms of depression. It targets adults with major depressive disorder (MDD) who do not have psychotic features. Solriamfetol works by affecting brain chemicals involved in mood regulation, potentially helping to improve mood and reduce depression symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Eligibility Criteria

This trial is for adults with major depressive disorder (MDD) who meet specific health criteria. The exact inclusion and exclusion details are not provided, but typically participants should have a diagnosis of MDD and be in stable health.

Inclusion Criteria

I have been diagnosed with major depression without psychosis.

I am currently experiencing a major depressive episode.

Exclusion Criteria

I have previously taken solriamfetol/Sunosi.

Unable to comply with study procedures

Medically inappropriate for study participation in the opinion of the investigator

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either solriamfetol (300 mg) or placebo for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Solriamfetol

Trial Overview The PARADIGM study tests the safety and effectiveness of Solriamfetol, a stimulant medication, against a placebo in treating MDD. Participants will randomly receive either Solriamfetol 300 mg or an inactive pill without knowing which one they're taking.

Participant Groups

Group I: Solriamfetol 300 mg Experimental Treatment 1 Intervention

Up to 6 weeks

Group II: Placebo Placebo Group 1 Intervention

Up to 6 weeks

Solriamfetol is already approved in United States for the following indications:

Approved in United States as Sunosi for:

• Excessive daytime sleepiness in patients with narcolepsy
• Excessive daytime sleepiness in patients with obstructive sleep apnea

Who Is Running the Clinical Trial?

Axsome Therapeutics, Inc.

Lead Sponsor

Trials

34

Recruited

11,600+