Phase 2 Study of R-Ketamine Hydrochloride Nasal Spray to Treat Depression and Acute Suicidal Thoughts or Behavior in Adults

What this Trial Is About

Researchers are evaluating the effects of PRT-042 nasal spray in adults with major depressive disorder MDD who have acute suicidal thoughts or behaviors. This Phase 2 study aims to assess how well the nasal spray reduces depressive symptoms rapidly and to understand its safety and how the body processes the drug when given multiple doses. The study focuses on adults aged 18 to 64 years with significant depression and suicidal ideation. Participants will be randomly assigned to receive one of four treatments low dose, medium dose, or high dose of PRT-042 nasal spray, or a placebo. All treatments are given twice a week for four weeks. The study is double-blind, meaning neither participants nor researchers know which treatment is given. This design helps evaluate the nasal sprays effects accurately and monitor participants closely over the treatment period. During the study, participants will have regular assessments including depression rating scales like the Montgomery Asberg Depression Rating Scale MADRS, measurements of suicidal thoughts, and safety monitoring such as vital signs and lab tests. These evaluations occur at multiple points, including before treatment, 24 hours after the first dose, and throughout the 25-day double-blind phase. Researchers will also study how the drug moves through and is eliminated from the body. The total duration of participation covers the initial screening, treatment, and follow-up assessments.

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