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Aticaprant · 3 trials · 3 indications
The MADRS is a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score is the sum of scores from individual question items, which ranges from 0 to 60; higher scores represent a more severe condition. Negative change in MADRS total score indicates improvement.
Screening pass rate of participants will be reported.
Assessment specific completion rate of participants will be reported.
The C-SSRS is a clinical interview providing a summary of both ideation and behavior that can be administered during any evaluation or risk assessment to identify the occurrence and intensity of suicidal thoughts and suicidal behaviors.
| Arm | Type | Description |
|---|---|---|
| Aticaprant | EXPERIMENTAL | Participants will receive Aticaprant 10 milligrams (mg) tablet orally, once daily for 42 days during double-blind (DB) treatment phase in addition to their current antidepressant selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) therapy. Participants who will complete the DB treatment phase (Day 43) may be eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo tablet orally, once daily for 42 days during DB treatment phase in addition to their current antidepressant SSRI/SNRI therapy. Participants who will complete the DB treatment phase (Day 43) may be eligible to participate in a separate 52-week open-label long-term safety study 67953964MDD3003. |
| Arm A: Aticaprant | EXPERIMENTAL | Participants will receive aticaprant during the double blind (DB) treatment phase. |
| Arm B: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo during the DB treatment phase. |
| Name | Type | Description |
|---|---|---|
| Aticaprant | DRUG | Aticaprant tablet will be administered orally. |
| Placebo | OTHER | Placebo tablet will be administered orally. |
Inclusion Criteria: * Be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and baseline * Have a Hamilton depression rating Scale 17 item (HDRS-17) total score of 20 or higher at the first and second scree...
Aticaprant is an investigational small molecule being developed for use in major depressive disorder (MDD) with moderate-to-severe anhedonia and as an adjunctive treatment in schizophrenia. It is studied as an add-on therapy for adults with inadequate response to current antidepressant therapy.
Aticaprant is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting clinical trials to evaluate the drug as an adjunctive treatment for major depressive disorder with anhedonia and for schizophrenia.
Aticaprant is in Phase 3 clinical development for major depressive disorder with anhedonia. Two Phase 3 trials have been completed. A separate Phase 1 trial is currently recruiting participants to study the drug as an adjunctive treatment in schizophrenia.
Aticaprant has been studied in two completed Phase 3 trials: NCT05455684 and NCT05550532, both evaluating the drug as adjunctive therapy in adults with MDD with moderate-to-severe anhedonia. An ongoing Phase 1 trial, NCT07615426, is recruiting to study the drug in schizophrenia.
Aticaprant is not FDA approved. It is an investigational drug currently in clinical development. Completed Phase 3 trials have evaluated its use in major depressive disorder with anhedonia, but the drug has not yet received regulatory approval.
Aticaprant is a small molecule being studied as an adjunctive treatment for major depressive disorder with anhedonia and for schizophrenia. Its specific molecular target has not been disclosed in the available clinical trial information.