Solriamfetol for Depression

(PARADIGM Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called solriamfetol to determine its effectiveness in treating major depressive disorder (MDD). Researchers aim to assess whether solriamfetol is safe and effective for individuals experiencing a current major depressive episode. Participants will receive either solriamfetol or a placebo (a pill with no active drug) for up to six weeks. Suitable candidates have ongoing major depressive disorder but have not previously tried solriamfetol. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment for MDD.

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.

Is there any evidence suggesting that solriamfetol is likely to be safe for humans?

Research has shown that solriamfetol is generally well-tolerated. In one study, about one-third of participants experienced side effects, with headaches and reduced appetite being the most common, affecting 9% and 7% of participants, respectively. Another study found the treatment safe even for individuals with a history of depression. The FDA has already approved solriamfetol for treating excessive daytime sleepiness in conditions like narcolepsy, indicating a good safety record. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Solriamfetol is unique because, unlike traditional antidepressants that typically affect serotonin, norepinephrine, or dopamine, it primarily targets the dopamine and norepinephrine pathways, offering a novel approach to managing depression. This mechanism, usually found in treatments for sleep disorders, may help improve energy and alertness, which are commonly affected in depression. Researchers are hopeful that Solriamfetol could provide faster relief of symptoms compared to current options, potentially offering benefits for individuals who haven't responded well to other antidepressant therapies.

What evidence suggests that solriamfetol might be an effective treatment for major depressive disorder?

Research has shown mixed results for solriamfetol in treating major depressive disorder (MDD). In one study, some patients improved, but results varied. Solriamfetol, which participants in this trial may receive, boosts alertness by increasing certain brain chemicals, such as dopamine and norepinephrine, which might help with depression. It has effectively helped people stay awake in other conditions, like sleep disorders. This suggests solriamfetol could also aid those with MDD, but more research is needed to confirm this. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. rheumatologyadvisor.com rheumatologyadvisor.com/news/mixed-results-solriamfetol-mdd-patients-excessive-daytime-sleepiness/

Mixed Results for Solriamfetol in MDD Patients W/Wo ... Topline results were announced from a phase 3 trial evaluating solriamfetol for the treatment of major depressive disorder (MDD) with and without severe ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11868153/

SURWEY real-world study of solriamfetol: initiation, titration ... 001). Improvement in patient- and physician-rated EDS was reported by ~ 90% of patients. Most patients (55%) reported effects of solriamfetol ...

3. academic.oup.com academic.oup.com/sleep/article/47/Supplement_1/A416/7655009

0970 Real-world Use of Solriamfetol for Excessive Daytime ... Ninety percent of patients achieved ≥2-point reduction in ESS scores from baseline and patients (≥89%) and physicians (≥91%) reported ...

4. neurologylive.com neurologylive.com/view/depression-history-shows-no-impact-efficacy-safety-solriamfetol-treating-obstructive-sleep-apnea-narcolepsy

Depression History Shows No Impact on Efficacy, Safety of ... At the conclusion of the treatment period, results showed that MWT sleep latency improved by 5.4 mins and 7.0 mins among those with and without ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7393785/

Effects of Solriamfetol on Quality-of-Life Measures from a ... Common adverse events were headache, nausea, decreased appetite, and anxiety. Conclusions: Solriamfetol improved measures of functioning, quality of life, and ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S002239562200471X

Solriamfetol treatment of excessive daytime sleepiness in ... This study suggests that safety and efficacy of solriamfetol for treating EDS in narcolepsy and OSA are not affected by depression history.