A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SPN-821 as an Adjunctive Therapy in Adults With Major Depressive Disorder
Supernus Pharmaceuticals, Inc.
Summary
This study will evaluate the efficacy and safety of SPN-821 in adults with major depressive disorder
Description
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of SPN-821 administered twice a week as adjunctive therapy to an approved antidepressant therapy in adult participants with MDD. The study includes a 2-week Screening Period, a 4-week Double blind Treatment Period, and a Safety Follow-up phone call one week after the completion of the Treatment Period.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Current diagnosis of MDD according to the DSM-5 for either single or recurrent MDE without psychotic features confirmed by the MINI * Duration of current MDE of at least 8 weeks * MADRS total score of ≥ 24 at the Screening Visit and Day 1 Visit * CGI-S score of ≥ 4 (moderately ill or worse) at the Screening Visit and Day 1 Visit * Stable, therapeutic dose of one of the following protocol-approved ADTs as a monotherapy for ≥ 8 weeks before the Screening Visit and ≥ 10 weeks at the Day 1 Visit. Additionally, inadequate response to the current ADT (less than 50% improvement…
Interventions
- DrugSPN-821 2400 mg
SPN-821 is a novel, orally bioavailable, selective, direct enhancer of mTORC1 cellular signaling
- DrugPlacebo
Matched placebo oral tablets
Location
- Collaborative Neuroscience NetworkGarden Grove, California