SPN-820 for Depression

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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called SPN-820 to see if it helps adults with depression feel better when added to their current treatment.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+