Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder

Part of paid clinical trials in Garden Grove, California.

Sponsor
Supernus Pharmaceuticals, Inc.
Study ID
NCT07226661
Phase
PHASE2
Status
Recruiting
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Conditions

  • Major Depressive Disorder (MDD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • SPN-821 2400 mg — DRUG
    SPN-821 is a novel, orally bioavailable, selective, direct enhancer of mTORC1 cellular signaling
  • Placebo — DRUG
    Matched placebo oral tablets

Study Details

This study will evaluate the efficacy and safety of SPN-821 in adults with major depressive disorder

Key Dates

Start date
Jan 19, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
230 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SPN-821 2400 mg
    Three 800 mg oral tablets administered twice a week adjunctive to current antidepressant
  • Placebo Comparator: Placebo
    Three oral tablets administered twice a week adjunctive to current antidepressant

Primary Outcome Measure

Change From Baseline to Day 29 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Collaborative Neuroscience NetworkGarden GroveCalifornia92845-

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Collaborative Neuroscience Network· Garden Grove, CA

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