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JNJ-67953964 · 3 trials · 2 indications
The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts. Negative change from baseline indicates improvement.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Plasma samples will be analyzed to determine concentrations of JNJ-67953964 using a fully validated liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) method.
Plasma samples will be analyzed to determine concentrations of JNJ-67953964 using a fully validated LC-MS/MS method.
Microscopic signs of parietal cell damage is defined as the any of the following observations to be present in at least 2 biopsy specimens collected during a gastroscopy session: greater than (\>) 25 percent (%) decrease in the number of parietal cells from baseline in the gastric biopsies at visit 4 or multifocal to diffuse parietal cell apoptosis or degeneration.
| Arm | Type | Description |
|---|---|---|
| Lead-in Period: Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo for the entire duration of the lead-in period. |
| Treatment Period: JNJ-67953964 or Placebo | EXPERIMENTAL | Participants who respond or do not respond (based on reduction from lead-in baseline in MADRS) in the placebo lead-in period will receive either matching placebo or 10 (2\*5) milligram (mg) JNJ-67953964 capsules in a 1:1 ratio for 6 weeks. |
| Withdrawal Period: Placebo | PLACEBO_COMPARATOR | Participants who complete the double-blind treatment period prior to the end of Week 11 will receive matching placebo for the remaining time of the treatment phase of the study. |
| Single Dose Cohort: Cohort 1 and 2 | EXPERIMENTAL | Participants will receive a single oral dose of JNJ-67953964 or a matching placebo on Day 1. |
| Multiple Dose Cohort: Cohort 3 | EXPERIMENTAL | Participants will receive multiple oral dose of JNJ-67953964 once daily or a matching placebo up to Day 14. |
| Cohort 1: JNJ-67953964 or Placebo | EXPERIMENTAL | Participants will receive JNJ-67953964 or matching placebo oral capsules once daily (QD) over 4 weeks (28 days). |
| Cohort 2: JNJ-67953964 or Placebo | EXPERIMENTAL | Participants in this cohort will receive JNJ-67953964 only or will be randomly assigned to receive JNJ-67953964 or matching placebo. |
| Name | Type | Description |
|---|---|---|
| JNJ-67953964 | DRUG | JNJ-67953964 10 mg will be administered as two 5-mg capsules orally once daily. |
| Placebo | DRUG | Matching placebo will be administered as 2 capsules orally once daily. |
Inclusion Criteria: * Have a Body Mass Index (BMI) between 18 and 35 kilogram per meter square (kg/m\^2) inclusive (BMI = weight/height\^2) * Participants must be medically stable based on clinical laboratory tests, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at scre...
JNJ-67953964 is an investigational small molecule being studied for the treatment of major depressive disorder. It has also been evaluated in healthy volunteers in early-phase studies. The drug is in clinical development by Johnson & Johnson and is not yet approved.
JNJ-67953964 is a small molecule in development for psychiatry. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being investigated for its effects on major depressive disorder.
JNJ-67953964 is being developed by Johnson & Johnson, a pharmaceutical company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical trials to evaluate the drug for major depressive disorder and in healthy participants.
JNJ-67953964 is in Phase 2 clinical development for major depressive disorder. A Phase 2 trial has been completed, along with two Phase 1 studies in healthy volunteers. The drug remains investigational and has not received FDA approval.
JNJ-67953964 has been studied in three completed trials. NCT03559192 was a Phase 2 study in 181 participants with major depressive disorder. NCT04185051 and NCT04791332 were Phase 1 studies in healthy volunteers, with the latter enrolling Japanese male participants.
JNJ-67953964 is the only name provided for this investigational drug. No alternative names have been reported in the clinical trial records. It is being developed by Johnson & Johnson for major depressive disorder.