---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-033148"
form_type: "8-K"
ticker: "AXSM"
cik: "0001579428"
company_name: "Axsome Therapeutics, Inc."
filed_at: "2024-03-19T23:59:59+00:00"
generated_at: "2026-06-04T13:22:09.252747+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Axsome doses first patient in PARADIGM Phase 3 trial of solriamfetol for MDD

## Summary
- First patient dosed in Phase 3 PARADIGM trial of solriamfetol for major depressive disorder.
- Randomized, double-blind, placebo-controlled trial with ~300 patients (1:1 ratio, 300 mg or placebo for 6 weeks).
- Primary endpoint is change in Montgomery-Åsberg Depression Rating Scale (MADRS).
- Solriamfetol is an investigational treatment; Axsome specializes in CNS disorders.

## SEC filing metadata
- accession: 0000950170-24-033148
- form_type: 8-K
- ticker: AXSM
- cik: 0001579428
- company_name: Axsome Therapeutics, Inc.
- filed_at: 2024-03-19T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1579428/000095017024033148/0000950170-24-033148-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1579428/000095017024033148/axsm-20240319.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-033148
- JSON: https://secwatch.observer/filing/0000950170-24-033148.json
- Plain text: https://secwatch.observer/filing/0000950170-24-033148.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.