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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 is a Phase 3 study that has completed, run by Axsome Therapeutics. The registered enrollment target is 346 participants.

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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

FieldValue
Enrollment Target 346 participants
Start Date 2024-03-18
Est. Completion 2025-03-26
Phase Phase 3

Sponsor

Axsome Therapeutics

28 total trials

What the Registry Record Tells You About NCT06360419

The ClinicalTrials.gov registry entry for NCT06360419 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 346 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Axsome Therapeutics, which has 28 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT06360419 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.