drugset / Trial / NCT07193901
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
RandomizedParallel-groupQuadruple-blindTreatment
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
Timeline
- Start
- 2025-05-27
- Primary completion
- 2026-06
- Completion
- 2026-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PRT042 | Unknown | — | Intranasal |