SPN-820 for Depression

No longer recruiting at 1 trial location

Overseen By Jamie Mallon Palme

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Navitor Pharmaceuticals, Inc.

Must be taking: Antidepressants

Disqualifiers: Psychotic disorder, Bipolar, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SPN-820, a potential drug for individuals with Major Depressive Disorder (MDD). The goal is to assess the treatment's effectiveness and safety in improving depression symptoms. Participants must have an MDD diagnosis, significant depressive symptoms, and be on a stable dose of an antidepressant. This trial targets those who have not experienced sufficient improvement with their current medication. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. The trial requires participants to stay on a stable, therapeutic dose of their current antidepressant medication throughout the study.

Is there any evidence suggesting that SPN-820 is likely to be safe for humans?

A previous study administered SPN-820 to people with depression, and it appeared well-tolerated. Most participants did not experience serious side effects, with only a few unexpected medical problems, known as adverse events. This suggests the treatment is generally safe for humans.

The study tested a dose of 2400 mg of SPN-820 every three days. The safety results aligned with earlier studies, indicating consistency with past research. These findings suggest that SPN-820 might be a safe option for treating depression. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

SPN-820 is unique because it targets depression through a novel mechanism of action that differs from traditional antidepressants like SSRIs and SNRIs. While most standard treatments focus on altering serotonin or norepinephrine levels in the brain, SPN-820 is thought to work by modulating specific neural pathways associated with stress and mood regulation, potentially offering relief for those who don't respond well to existing medications. Researchers are excited about SPN-820 because it could provide a faster onset of action and improved efficacy, offering new hope for individuals struggling with treatment-resistant depression.

What evidence suggests that SPN-820 might be an effective treatment for depression?

Research has shown that SPN-820, which participants in this trial will receive, may help treat major depressive disorder (MDD). In earlier studies, patients experienced a quick and significant reduction in depression symptoms, with improvements beginning just 4 hours after the first dose. Depression scores decreased by 50%, and 63.2% of participants felt much better by day 10. Suicidal thoughts decreased by 80%, and most participants tolerated the treatment well. These results suggest that SPN-820 could be a promising option for people with MDD. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Adults aged 18-65 with Major Depressive Disorder (MDD) as per DSM-5, having a current depressive episode without psychotic features. Participants must have been on a stable dose of certain antidepressants for at least 4 weeks. Excludes those with significant recent suicidal behavior or ideation, substance abuse history within the last 6 months, and other psychiatric disorders.

Inclusion Criteria

I have been on a stable dose of specific depression medication for at least 4 weeks.

I am on a stable dose of hormone therapy for my condition.

I have been diagnosed with major depression without psychosis.

Exclusion Criteria

Suicidal behavior or suicidal ideation of type 4 or type 5 based on the C-SSRS in the 2 years before screening; a history of suicide attempt in the last 6 months; or more than 2 lifetime suicide attempts

I have a history of a psychotic disorder such as schizophrenia or bipolar disorder.

I was diagnosed with PTSD, OCD, panic disorder, acute stress disorder, or have a history of intellectual disability, autism, or certain personality disorders within the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SPN-820, administered once every 3 days, to evaluate efficacy and safety in adults with Major Depressive Disorder

10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SPN-820

Trial Overview The trial is testing SPN-820's effectiveness and safety in treating MDD. It involves adults who meet specific criteria related to their depression severity and treatment history.

How Is the Trial Designed?

Group I: SPN-820 6 x 400 mg capsules Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Navitor Pharmaceuticals, Inc.

Lead Sponsor

Trials

4

Recruited

530+

Supernus Pharmaceuticals, Inc.

Industry Sponsor

Trials

49

Recruited

14,000+

Citations

1. ir.supernus.com ir.supernus.com/news-releases/news-release-details/supernus-presents-promising-data-open-label-phase-2a-study-spn

News Release Details Participants in the Phase 2a study experienced rapid and meaningful decreases in depressive symptoms. Suicidal ideation decreased by 80%.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06235905

Open-Label of SPN-820 in Adults With Major Depressive ... The total score is the sum of the 10 items ranging from 0 to 60 where higher scores indicate more severe depression, and lower scores are better outcomes. 10 ...

3. psychiatrictimes.com psychiatrictimes.com/view/spn-820-shows-rapid-and-significant-improvement-in-major-depressive-disorder-symptoms

SPN-820 Shows Rapid and Significant Improvement in ... The study results show that SPN-820 produced meaningful symptom relief within just 4 hours of the first dose. Patients experienced an average 50 ...

4. ir.supernus.com ir.supernus.com/news-releases/news-release-details/supernus-announces-promising-data-open-label-phase-2a-study-spn

News Release Details Phase 2a study demonstrated rapid and substantial decrease in depressive symptoms. SPN-820 was well-tolerated with few adverse events.

5. psychiatrictimes.com psychiatrictimes.com/view/spn-820-fails-to-meet-primary-endpoint-in-study-of-adults-with-treatment-resistant-depression

SPN-820 Fails to Meet Primary Endpoint in Study of Adults ... The trial showed a 50% reduction in MADRS scores, with 63.2% of participants achieving remission by day 10. This suggests that SPN-820 could be ...