Tier 2 — strong
A phase 2, multicenter, double-blind, randomized, placebo-controlled study of the safety and efficacy of forvisirvat (SP-624) in the treatment of adults with major depressive disorder
Current Medical Research and Opinion
2025
41(9):1723-1734
Bibliography
- PubMed
- PMID 41099447
- Trial registry
- View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
- Funding
- Industry-sponsored development program for forvisirvat/SP-624; several authors are affiliated with Sirtsei Pharmaceuticals / Arrivo BioVentures.
- Competing interests
- The study was funded by Sirtsei Pharmaceuticals, a wholly owned subsidiary of Arrivo BioVentures. Several authors were Sirtsei consultants and held minority equity interests in Arrivo BioVentures; other academic authors reported additional industry relationships detailed in the publication.
Study snapshot
| Design | Multicenter Phase 2 double-blind randomized placebo-controlled trial. |
|---|---|
| Model | Adults with moderate-to-severe major depressive disorder. |
| Sample | 319 randomized: 163 forvisirvat and 156 placebo; 317 treated. |
| Intervention | Forvisirvat (SP-624) 20 mg orally once daily versus placebo. |
| Duration | 4 weeks. |
| Endpoints | Change in MADRS score at Week 4; secondary depression efficacy measures; treatment-emergent adverse events; discontinuations |
What the study showed, in plain terms
Key findings
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