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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02902601 | A Study to Investigate the Safety, Tolerability, and Pharmacodynamics of JNJ-54175446 in Participants With Major Depressive Disorder | PHASE1 | COMPLETED | 70 | — | — | Oct 17, 2016 | Jun 7, 2017 | Apr 27, 2025 | 4 | Germany, Netherlands |
| Arm | Type | Description |
|---|---|---|
| Group A: JNJ-54175446 | EXPERIMENTAL | Participants will receive a loading dose of JNJ-54175446, 600 milligram (mg) on Day 1 followed by JNJ-54175446, 150 mg once daily until Day 10. |
| Group B: Placebo + JNJ-54175446 | EXPERIMENTAL | Participants will receive placebo on Days 1 to 3 followed by a loading dose of JNJ-54175446, 600 mg on Day 4 followed by JNJ-54175446, 150 mg once daily until Day 10. |
| Group C: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo from Day 1 until Day 10. |
| Name | Type | Description |
|---|---|---|
| JNJ-54175446, 600 mg | DRUG | Participants will receive JNJ-54175446, 600 mg as an oral suspension. |
| JNJ-54175446, 150 mg | DRUG | Participants will receive JNJ-54175446, 150 mg as an oral suspension. |
| Placebo | OTHER | Matching placebo to JNJ-54175446 |
Inclusion Criteria: * Body mass index (BMI) must be between 18 and 32 kilogram per square meter (kg/m\^2) inclusive * Related to symptoms of depression: Participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV or V diagnostic criteria for Major Depressive Disorder \[...