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CompletedPhase 2

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 · Sichuan Purity Pharmaceutical Technology Co., Ltd.

Closed to entry
Status
Not accepting participants
Phase 2
Phase
98
Target enrolment
15
Study sites
Outside the US

What it is testing

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

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

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

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

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 64 Years
Ages
All
Sex
Not accepted
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.

Where

15 study sites

FacilityCityRegionCountry
The Sixth Hospital of Peking UniversityBeijin-China
BEIjing AnDing hospital capital medical universityBeijing-China
Beijing Huilongguan HospitalBeijing-China
Brain Hospital of Hunan ProvinceChangsha-China
The Second Xiangya Hospital of Central South UniversityChangsha-China
The Fourth People's Hospital of ChengduChengdu-China
Hangzhou Seventh People's HospitalHangzhou-China
Hefei Fourth People's Hospital(Anhui Mental Health Prevention and Treatment Center)Hefei-China
The fourth affiliated hospital of Anhui medical universityHefei-China
The Affiliated Hospital of Southwest Medical UniversityLuzhou-China
The First Affiliated Hospital of Nanchang UniversityNanchang-China
The affiliated Kangning Hospital of Ningbo UniversityNingbo-China
Suzhou Guangji HospitalSuzhou-China
Wuxi Mental Health CenterWuxi-China
Zhumadian Second People's Hospital(Zhumadian Psychiatric Hospital )Zhumadian-China

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record. The registry also holds the most current version of everything above.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07193901 on ClinicalTrials.gov →

Last updated in the registry 2026-09-09. Registry records change; this page reflects the data build of 2026-10-06.

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Where this trial sits