| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04080752 | A Study of JNJ-61393215 in the Treatment of Depression | PHASE2 | COMPLETED | 222 | — | — | Sep 17, 2019 | Sep 2, 2021 | Apr 29, 2025 | 35 | United States, Moldova +3 |
Change from baseline in HDRS-17 total score at Week 6 was reported. The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (range: 0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition (greater depression).
| Arm | Type | Description |
|---|---|---|
| JNJ-61393215 135 milligram (mg) | EXPERIMENTAL | Participants will receive JNJ-61393215 135 mg (3\*45 mg capsules) orally once daily for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo for 6 weeks along with the prescribed standard oral antidepressants (without dose change) throughout the study. |
| Name | Type | Description |
|---|---|---|
| JNJ-61393215 | DRUG | JNJ-61393215 will be administrated orally. |
| Placebo | DRUG | Matching placebo will be administered orally. |
Inclusion Criteria: * Participants must have a body mass index (BMI) between 18 and 36 kilogram per meter square (kg/m\^2) * Participants must have a primary diagnostic and statistical manual of mental disorders, 5th edition (DSM-5) diagnosis of major depressive disorder (MDD) with anxious distress...