Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE2 | RECRUITING | 98 | — | — | May 27, 2025 | Jun 1, 2026 | Jan 22, 2026 | 8 | China |
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.
| Arm | Type | Description |
|---|---|---|
| Low Dose PRT042 nasal spray | EXPERIMENTAL | - |
| median Dose PRT042 nasal spray | EXPERIMENTAL | - |
| high Dose PRT042 nasal spray | EXPERIMENTAL | - |
| placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Low Dose PRT042 nasal spray | DRUG | two times a week, for 4 weeks |
| median Dose PRT042 nasal spray | DRUG | two times a week, for 4 weeks |
| high dose PRT042 nasal spray | DRUG | two times a week, for 4 weeks |
| placebo | DRUG | two times a week, for 4 weeks |
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 ...