RecruitingPhase 2NCT07193901

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


Sponsor

Sichuan Purity Pharmaceutical Technology Co., Ltd.

Enrollment

98 participants

Start Date

May 27, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a nasal spray version of (R)-ketamine — a rapid-acting drug — can quickly reduce suicidal thoughts and depression symptoms in people who are currently experiencing major depression with active suicidal intent. **You may be eligible if...** - You are an adult who has been diagnosed with major depressive disorder (MDD) without psychotic features - You currently have suicidal thoughts with intent to act on them (confirmed by a structured psychiatric interview) - Your depression severity score (MADRS) meets the required threshold at screening **You may NOT be eligible if...** - You do not have a confirmed MDD diagnosis - You do not have current active suicidal ideation with intent - You have psychotic features alongside your depression - Your depression severity score is below the required level - You have other conditions that would make ketamine unsafe for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLow Dose PRT042 nasal spray

two times a week, for 4 weeks

DRUGmedian Dose PRT042 nasal spray

two times a week, for 4 weeks

DRUGhigh dose PRT042 nasal spray

two times a week, for 4 weeks

DRUGplacebo

two times a week, for 4 weeks


Locations(8)

BEIjing AnDing hospital capital medical university

Beijing, China

Beijing AnDing hospital capital medical university

Beijing, China

Beijing Huilongguan Hospital

Beijing, China

The Fourth People's Hospital of Chengdu

Chengdu, China

Hangzhou Seventh People's Hospital

Hangzhou, China

The fourth affiliated hospital of Anhui medical university

Hefei, China

The affiliated Kangning Hospital of Ningbo University

Ningbo, China

Suzhou Guangji Hospital

Suzhou, China

View Full Details on ClinicalTrials.gov

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NCT07193901


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