Recruiting
Phase 2

SPN-821

Sponsor:

Supernus Pharmaceuticals, Inc.

Code:

NCT07226661

Conditions

Major Depressive Disorder (MDD)

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

SPN-821 2400 mg

Placebo

Study Details

Brief summary:

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

Conditions

Major Depressive Disorder (MDD)

Study ID

NCT07226661

Start date

Jan 19, 2026

Status verified date

Mar, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 in depressive symptoms) as confirmed by the ATRQ Investigator administered.

Exclusion Criteria:

  • MADRS total score change of ≥ 25% from the Screening Visit to Day 1 Visit
  • History of treatment resistant depression (TRD) defined as 3 or more failed ADTs of adequate dose (per ATRQ) and duration (at least 8 weeks) for the current MDE
  • History of alcohol or substance use disorder according to DSM-5 criteria 6 months before the Screening Visit
  • Evidence of significant risk for suicidal behavior during participation in the study in the Investigator's opinion
  • Lifetime diagnosis of any psychotic disorder including MDD with psychosis, MDD with mixed features, bipolar I/II disorder, bipolar depression, schizophrenia, posttraumatic stress disorder, autism spectrum disorder, or any personality disorder or intellectual disability that would affect the ability of the participant to enroll in the study
  • Diagnosis less then 12 months before screening of severe obsessive-compulsive disorder, acute stress disorder, panic disorder, eating disorders, or any other psychiatric condition that has been the primary focus of treatment, or diagnosis of generalized anxiety disorder less then 6 months before screening.
  • History of cardiovascular, respiratory, gastrointestinal, renal, hepatic, and hematologic disorders, or other medical disorders that could impose undue risk or compromise the study in the Investigator's opinion
  • Clinically significant abnormal result prior to Day 1 Visit per Investigator's judgment or abnormal renal function.
  • Requires treatment with a medication or other substance that is prohibited by the protocol.

Study Design

Enrollment

230 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

SPN-821 2400 mg

SPN-821 is a novel, orally bioavailable, selective, direct enhancer of mTORC1 cellular signaling

Placebo

Matched placebo oral tablets

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 and Locations

Central contacts

Gianpiera Ceresoli-Borroni, PhD

301-838-2521gceresoliborroni@supernus.com

Locations

Collaborative Neuroscience Network

Recruiting

Garden Grove, California, United States, 92845

More Information

Sponsor

Supernus Pharmaceuticals, Inc.

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Supernus Pharmaceuticals, Inc. on 2026-03-24.