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Solriamfetol 300 mg 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

PARADIGM Trial 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.

PARADIGM Trial 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)

PARADIGM 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
28 Previous Clinical Trials
7,892 Total Patients Enrolled
8 Trials studying Depression
2,470 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals such as myself participate in this clinical study?

"Participants must have a diagnosis of depression and be between 18 and 65 years old to meet the eligibility criteria for this trial, which aims to enroll approximately 300 individuals."

Answered by AI

In how many medical institutions is this clinical examination currently being conducted?

"At present, enrollment for this study is ongoing at 23 medical centers. These include sites in Riverside, Brooklyn, and Encino among other locations. Opting for the nearest site can reduce travel obligations should you choose to take part."

Answered by AI

What is the current number of participants being enrolled in this research project?

"Affirmative. Information posted on clinicaltrials.gov confirms that this research trial, initially shared on March 18th, 2024, is actively seeking participants. The study aims to recruit around 300 patients from a network of 23 sites."

Answered by AI

Does this study include individuals older than 45 years?

"The study is enrolling participants over 18 years old but under the age of 65."

Answered by AI

What is the safety profile of a 300 mg dose of Solriamfetol in individuals?

"According to our team at Power, the safety rating for Solriamfetol 300 mg is a perfect score of 3. This high rating is attributed to the trial being in Phase 3 with existing efficacy data and extensive safety records."

Answered by AI

Who else is applying?

What site did they apply to?
Clinical Research Site
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I’ve tried multiple antidepressants to no avail. This feels like a long shot but it’s worth a try to stop feeling this way; I want to live again.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol
2024. "Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06360419.
All > Depression Los Angeles > Greensboro
~200 spots leftby Dec 2025
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