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Also known as Orexin-1
JNJ-61393215 · 1 trial · 1 indication
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...
JNJ-61393215 is an investigational small molecule being developed by Johnson & Johnson for Major Depressive Disorder With Anxious Distress. It has completed a Phase 2 clinical trial and is not approved for any indication. The drug is designed as a psychiatric treatment and has been studied in a placebo-controlled setting.
JNJ-61393215 is being studied for the treatment of Major Depressive Disorder With Anxious Distress. This indication combines depressive symptoms with significant anxiety. The drug is investigational and has not been approved for any use. Its development is focused on this specific psychiatric condition.
JNJ-61393215 is being developed by Johnson & Johnson, which trades under the ticker symbol JNJ. The company is responsible for the clinical development of this small molecule for Major Depressive Disorder With Anxious Distress.
JNJ-61393215 is in Phase 2 development. It has completed one Phase 2 clinical trial, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA or any regulatory agency for any indication.
JNJ-61393215 has been studied in a completed Phase 2 trial, NCT04080752, titled A Study of JNJ-61393215 in the Treatment of Depression. The trial enrolled 222 participants across the United States, Moldova, Russia, Ukraine, and the United Kingdom. It was randomized, double-blind, and placebo-controlled.