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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05328297 | A Study of JNJ-55308942 in the Treatment of Bipolar Depression | PHASE2 | COMPLETED | 116 | — | — | Jun 3, 2022 | May 17, 2024 | Jul 11, 2025 | 44 | United States, Canada +2 |
Change from baseline in MADRS total score up to Week 6 were reported. MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant (AD) treatment. The MADRS evaluated reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. The scale consisted of 10 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms),with higher score indicating a more severe condition. The MADRS total score was the sum of scores from individual question items and it ranged from 0 to 60, with higher scores indicated more severe conditions. Negative change in MADRS total score indicated improvement.
| Arm | Type | Description |
|---|---|---|
| JNJ-55308942 | EXPERIMENTAL | Participants will receive a JNJ-55308942 capsule once daily for 6 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a matching placebo capsule once daily for 6 weeks. |
| Name | Type | Description |
|---|---|---|
| JNJ-55308942 | DRUG | JNJ-55308942 capsules will be administered orally. |
| Placebo | DRUG | Matching placebo capsules will be administered orally. |
Inclusion Criteria: * Have a primary diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnosis of bipolar disorder (BD) (Type I or II) without current psychotic features, as confirmed by the mini international neuropsychiatric interview (MINI) * Medically stable on the b...