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Also known as JNJ-55308942
JNJ-55308942 High Dose · 1 trial · 1 indication
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...
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| AbbVie, Inc. | ABBV | 3 | PHASE3 | Cariprazine, ABBV-932, Icalcaprant |
| Xenon Pharmaceuticals Inc. | XENE | 2 | PHASE3 | Azetukalner |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Rapport Therapeutics, Inc. | RAPP | 1 | PHASE2 | RAP-219 |
| Neurocrine Biosciences, Inc. | NBIX | 1 | PHASE2 | NBI-1117568 |
| Alto Neuroscience, Inc. | ANRO | 1 | PHASE2 | ALTO-100 |
| LB Pharmaceuticals, Inc. | LBRX | 1 | PHASE2 | LB-102 |
| BioXcel Therapeutics, Inc. | BTAI | 1 | PHASE1 | BXCL501 |
| Alzamend Neuro, Inc. | ALZN | 1 | PHASE1 | AL001 |
JNJ-55308942 high dose is being studied for the treatment of bipolar depression, a depressive phase of bipolar disorder. It is an investigational small molecule developed by Johnson & Johnson and has been evaluated in a Phase 2 clinical trial in adults with bipolar disorder.
JNJ-55308942 is developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored a Phase 2 study of the compound in bipolar depression across sites in the United States, Canada, Poland, and Spain.
JNJ-55308942 is in Phase 2 development. A Phase 2 trial in bipolar depression has been completed, and the compound remains investigational rather than approved for any indication.
JNJ-55308942 was evaluated in NCT05328297, titled A Study of JNJ-55308942 in the Treatment of Bipolar Depression. The Phase 2 trial enrolled 116 adults aged 18 and older, was randomized, double blind, and placebo controlled, and has been completed.