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NCT06360419 · ClinicalTrials.gov registry record · Phase 3
Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol
A Phase 3 study, sponsored by Axsome Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 346
- Enrollment target
NCT06360419: Completed Phase 3 study, sponsored by Axsome Therapeutics.
NCT06360419 is a Phase 3 study that has completed, run by Axsome Therapeutics. The registered enrollment target is 346 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06360419, a Phase 3 study, has completed, sponsored by Axsome Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 346 participants
- Enrollment target
Study Summary
PARADIGM (Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the safety and efficacy of solriamfetol for the treatment of major depressive disorder (MDD) in adults.
Interventions
- DRUG Placebo
- DRUG Solriamfetol 300 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 346 participants |
| Start Date | 2024-03-18 |
| Est. Completion | 2025-03-26 |
| Phase | Phase 3 |
What the finished NCT06360419 record still lists
NCT06360419 is an interventional study that assigns participants to a tested intervention. The registered 346 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06360419 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06360419 about?
NCT06360419 is a clinical study titled "Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol". PARADIGM (Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the safety and efficacy of solriamfetol for the treatment of major depressive disorder (MDD) in adults.
What is the current status of trial NCT06360419?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 346 participants. The study started on 2024-03-18. Estimated completion is 2025-03-26.
What interventions are being tested in trial NCT06360419?
The interventions under investigation include: Placebo (DRUG), Solriamfetol 300 mg (DRUG).
Who is sponsoring clinical trial NCT06360419?
This trial is sponsored by Axsome Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06360419's enrollment target sits among peer trials
346 1049th of 2000 higher than 951 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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