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

NCT07193901 | Recruiting Phase 2

• 1 other identifier: PRT042-II-01
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 8

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours After the First Dose (Day 2)

  The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.

  Baseline (Day 1, predose) and 24 hours first post dose (Day 2)

Secondary Outcomes (12)

• Change From Baseline in Montgomery Asberg Depression Rating Scale Total Score During Double-blind Phase

  Days 1 (4 hours postdose), 4, 8, 11, 15, 18, 22 and Day 25

• Number of Participants who Achieved Response （≥50% decrease from baseline MADRS total score）Through the Double-blind Phase

  Days 1 (4 hours postdose),2, 4, 8, 11, 15, 18, 22 and Day 25

• Number of Participants Who Achieved Remission (MADRS Total Score Less Than or Equal to [<=] 12) Through the Double-blind Phase

  Days 1 (4 hours postdose), 2, 4, 8, 11, 15, 18, 22 and Day 25

• 5. Change From Baseline in Clinical Global Impression- Severity of Suicidality-Revised (CGI-SS-R) During Double-blind Phase

  Days 1 (4 hours postdose), 2, 4, 8, 11, 15, 18, 22 and Day 25

• Number of Participants Who Achieved Resolution of Suicidality (CGI-SS-R Score of 0 or 1) Through Double-blind Phase

  up to Day 25

Study Arms (4)

Low Dose PRT042 nasal spray

EXPERIMENTAL

Drug: Low Dose PRT042 nasal spray

median Dose PRT042 nasal spray

EXPERIMENTAL

Drug: median Dose PRT042 nasal spray

high Dose PRT042 nasal spray

EXPERIMENTAL

Drug: high dose PRT042 nasal spray

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Low Dose PRT042 nasal spray DRUG

two times a week, for 4 weeks

Low Dose PRT042 nasal spray

median Dose PRT042 nasal spray DRUG

two times a week, for 4 weeks

median Dose PRT042 nasal spray

high dose PRT042 nasal spray DRUG

two times a week, for 4 weeks

high Dose PRT042 nasal spray

placebo DRUG

two times a week, for 4 weeks

placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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) .
• 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.
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sichuan Purity Pharmaceutical Technology Co., Ltd.: lead

Study Sites (8)

BEIjing AnDing hospital capital medical university

Beijing, China

RECRUITING

Beijing AnDing hospital capital medical university

Beijing, China

RECRUITING

Beijing Huilongguan Hospital

Beijing, China

RECRUITING

The Fourth People's Hospital of Chengdu

Chengdu, China

RECRUITING

Hangzhou Seventh People's Hospital

Hangzhou, China

RECRUITING

The fourth affiliated hospital of Anhui medical university

Hefei, China

RECRUITING

The affiliated Kangning Hospital of Ningbo University

Ningbo, China

RECRUITING

Suzhou Guangji Hospital

Suzhou, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

ke yao

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 26, 2025
• Study Start: May 27, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)