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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03559192 | A Study to Explore the Efficacy of JNJ-67953964 in the Treatment of Depression | PHASE2 | COMPLETED | 181 | — | — | Jul 16, 2018 | May 6, 2020 | Apr 29, 2025 | 53 | United States, Germany +4 |
The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale 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), summed for a total possible score of 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts. Negative change from baseline indicates improvement.
| Arm | Type | Description |
|---|---|---|
| Lead-in Period: Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo for the entire duration of the lead-in period. |
| Treatment Period: JNJ-67953964 or Placebo | EXPERIMENTAL | Participants who respond or do not respond (based on reduction from lead-in baseline in MADRS) in the placebo lead-in period will receive either matching placebo or 10 (2\*5) milligram (mg) JNJ-67953964 capsules in a 1:1 ratio for 6 weeks. |
| Withdrawal Period: Placebo | PLACEBO_COMPARATOR | Participants who complete the double-blind treatment period prior to the end of Week 11 will receive matching placebo for the remaining time of the treatment phase of the study. |
| Name | Type | Description |
|---|---|---|
| JNJ-67953964 | DRUG | JNJ-67953964 10 mg will be administered as two 5-mg capsules orally once daily. |
| Placebo | DRUG | Matching placebo will be administered as 2 capsules orally once daily. |
Inclusion Criteria: * Have a Body Mass Index (BMI) between 18 and 35 kilogram per meter square (kg/m\^2) inclusive (BMI = weight/height\^2) * Participants must be medically stable based on clinical laboratory tests, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at scre...