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SPN-821 · 1 trial · 1 indication
MADRS is a 10-item scale (Reported sadness, Apparent sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimist thoughts, and Suicidal thoughts) where each item is scored from 0 to 6. 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.
| Arm | Type | Description |
|---|---|---|
| SPN-821 2400 mg | EXPERIMENTAL | Three 800 mg oral tablets administered twice a week adjunctive to current antidepressant |
| Placebo | PLACEBO_COMPARATOR | Three oral tablets administered twice a week adjunctive to current antidepressant |
| Name | Type | Description |
|---|---|---|
| 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 |
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...
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SPN-821 is an investigational small molecule being developed for the treatment of Major Depressive Disorder (MDD). It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied in adults with MDD in a randomized, double-blind, placebo-controlled trial.
SPN-821 targets mTORC1, a protein complex involved in cellular growth and metabolism. By modulating mTORC1, the drug is being investigated for its potential therapeutic effect in Major Depressive Disorder. The exact mechanism of action in MDD is still under clinical investigation.
SPN-821 is being developed by Supernus Pharmaceuticals, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol SUPN. Supernus is conducting the Phase 2 clinical trial for SPN-821 in adults with Major Depressive Disorder.
SPN-821 is in Phase 2 clinical development. It is an investigational drug and has not yet been approved by the FDA. The ongoing Phase 2 trial is recruiting participants to evaluate the safety and efficacy of SPN-821 in adults with Major Depressive Disorder.
SPN-821 is being studied in one active Phase 2 clinical trial with the identifier NCT07226661. This trial is a double-blind, placebo-controlled study in adults with Major Depressive Disorder, with an enrollment target of 230 participants. The study is currently recruiting in the United States.