NCT07193901

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

A Randomized, Double-blind, Placebo-controlled Phase Il 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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Sichuan Purity Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

Conditions

• Major Depressive Disorder (MDD

Interventions

Type	Name	Description
DRUG	Low Dose PRT042 nasal spray	two times a week, for 4 weeks
DRUG	median Dose PRT042 nasal spray	two times a week, for 4 weeks
DRUG	high dose PRT042 nasal spray	two times a week, for 4 weeks
DRUG	placebo	two times a week, for 4 weeks

Timeline

• Start date: 2025-05-27
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-09-26
• Last updated: 2026-01-22

Locations

8 sites across 1 country: China