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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 up to 5 years
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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
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Who is running the clinical trial?
Axsome Therapeutics, Inc.Lead Sponsor
31 Previous Clinical Trials
10,627 Total Patients Enrolled
8 Trials studying Depression
2,504 Patients Enrolled for Depression
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