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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT07193901•Sichuan Purity Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participant must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) diagnostic criteria for Major Depressive Disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Mini International Psychiatric Interview (MINI) .
•2. Participants must have current suicidal ideation with intent, confirmed by a "Yes" response to Question B3 \[Think (even momentarily) about harming or of hurting or of injuring yourself: with at least some intent or awareness that you might die as a result; or think about suicide (ie, about killing yourself)?\] and Question B10 \[Intend to act on thoughts of killing yourself?\] obtained from the MINI.
•3. Participant has a Montgomery Asberg Depression Rating Scale (MADRS) total score of greater than (≥) 28 and the score for item 10"suicide ideation" of greater than (≥) 3 predose on Day 1

Exclusion Criteria

•1. Participant has a current DSM-5 diagnosis of bipolar (or related disorders), antisocial personality disorder, or obsessive compulsive disorder.
•2. Participant has a current clinical diagnosis of autism, dementia, or intellectual disability.
•3. Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychotic features .
•4. Participant meets the DSM-5 severity criteria for moderate or severe substance or alcohol use disorder, within the 6 months before screening
•5. Participant has a current or prior diagnosis of a reatment resistant depression
•6. Any nasal conditions or diseases that, in the investigator's judgment, may significantly affect the administration or absorption of a nasal product.
•7. Participant has a history of malignancy within 5 years before screening
•8. Pregnant or breastfeeding women, or those with a positive pregnancy test result during screening.
•9. Previous participation in another clinical trial and receiving the investigational drug within 3 months prior to dosing.

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

Key Dates

Start Date

May 27, 2025

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2026

Last Updated

January 22, 2026

Enrollment

ESTIMATED participants

Conditions

Major Depressive Disorder (MDD

Interventions

Low Dose PRT042 nasal spray

DRUG

median Dose PRT042 nasal spray

DRUG

high dose PRT042 nasal spray

DRUG

placebo

DRUG

Contacts

ke yao

CONTACT

86-028-85170738 ke.yao@btyy.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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