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high dose PRT042 nasal spray / Low Dose PRT042 nasal spray / median Dose PRT042 nasal spray · Phase 2 Trial
ClinicalTrials.gov · September 9, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 trial registration for (R)-ketamine nasal spray (PRT-042) in major depressive disorder with acute suicidal ideation or behavior. The study has completed enrollment (98 participants) with MADRS score change at 24 hours as the primary outcome, but results have not yet been posted in this registry record and cannot be evaluated.
Phase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Major Depressive Disorder (MDD; age from 18 Years; to 64 Years. Intervention: Low Dose PRT042 nasal spray; median Dose PRT042 nasal spray; high Dose PRT042 nasal spray. Compared with: placebo — Placebo Comparator. n = 98. 15 sites: China.
This is a Phase 2 trial registration for (R)-ketamine nasal spray (PRT-042) in major depressive disorder with acute suicidal ideation or behavior. The study has completed enrollment (98 participants) with MADRS score change at 24 hours as the primary outcome, but results have not yet been posted in this registry record and cannot be evaluated.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
Results from this Phase 2 trial could inform whether (R)-ketamine nasal spray warrants further evaluation in larger trials for rapid reduction of depressive symptoms and suicidality; however, efficacy and safety data are not yet available in this registry record.
Phase 2 trial with completed enrollment but no results posted; design and endpoint are stated but outcome data are not yet reported in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
Results from this Phase 2 trial could inform whether (R)-ketamine nasal spray warrants further evaluation in larger trials for rapid reduction of depressive symptoms and suicidality; however, efficacy and safety data are not yet available in this registry record.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07193901). This is a study registration, not published results. Lead sponsor: Sichuan Purity Pharmaceutical Technology Co., Ltd.. Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 98 participants (ACTUAL). Conditions: Major Depressive Disorder (MDD. Interventions: DRUG: Low Dose PRT042 nasal spray; DRUG: median Dose PRT042 nasal spray; DRUG: high dose PRT042 nasal spray; DRUG: placebo. Primary outcome measures: Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours After the First Dose (Day 2) , Baseline (Day 1, predose) and 24 hours first post dose (Day 2). 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
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.