Clinical Trial

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of (R)-Ketamine Hydrochloride Nasal Spray in Patients With Depression and Acute Suicidal Ideation or Behavior

Recruiting Phase 2
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Record status
This record was last updated January 22, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
The purpose of this study is to learn about: * To evaluate the efficacy of PRT-042 nasal spray for the Rapid Reduction of the depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior * To evaluate the safety and pharmacokinetic (PK) characteristics after multiple dose of PRT-042 nasal spray in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-18.
Trial Details
NCT Number NCT07193901
Lead Sponsor Sichuan Purity Pharmaceutical Technology Co., Ltd.
Conditions Major Depressive Disorder (MDD
Enrollment 98 participants
Start Date 2025-05-27
Primary Completion 2026-06 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2026-01-22