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Solriamfetol for Depression (PARADIGM Trial)

Phase 3
Recruiting
Research Sponsored by Axsome Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Summary

This trial, called PARADIGM, is testing a drug called solriamfetol to see if it is safe and effective in treating major depressive disorder in adults.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects for this trial aren't listed, common ones for stimulants like Solriamfetol may include trouble sleeping, increased heart rate, anxiety, headache, nausea, and appetite loss.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment-emergent adverse events
Montgomery-Åsberg Depression Rating Scale (MADRS)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Solriamfetol 300 mgExperimental Treatment1 Intervention
Up to 6 weeks
Group II: PlaceboPlacebo Group1 Intervention
Up to 6 weeks

Find a Location

Who is running the clinical trial?

Axsome Therapeutics, Inc.Lead Sponsor
30 Previous Clinical Trials
10,107 Total Patients Enrolled
8 Trials studying Depression
2,504 Patients Enrolled for Depression
~200 spots leftby Dec 2025