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Also known as JNJ-67953964
Aticaprant · 4 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.
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.
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. |
| 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. |
| 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. |
| JNJ-67953964 | DRUG | JNJ-67953964 10 mg will be administered as two 5-mg capsules orally once daily. |
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 major depressive disorder with moderate-to-severe anhedonia and for schizophrenia. In depression trials, it is studied as adjunctive therapy in adults with inadequate response to current antidepressant therapy. It is not approved and remains in clinical development.
Aticaprant targets the kappa opioid receptor, specifically the OPRK1 receptor, where it acts as an antagonist. By blocking this receptor, it may modulate pathways involved in mood and reward processing, which is relevant to its study in depression with anhedonia and schizophrenia.
Aticaprant is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical trials to evaluate the drug's safety and efficacy in psychiatric conditions.
Aticaprant is in Phase 3 clinical development for major depressive disorder with anhedonia, with two Phase 3 trials completed. It is also being studied in an earlier Phase 1 trial for schizophrenia, which is currently recruiting participants. The drug is investigational and not FDA approved.
Aticaprant has completed two Phase 3 trials: NCT05455684 and NCT05550532, both studying it as adjunctive therapy in adults with major depressive disorder and moderate-to-severe anhedonia. A Phase 1 trial, NCT07615426, is recruiting to study it as adjunctive treatment in schizophrenia.
Aticaprant is also known by the code name JNJ-67953964. It is a kappa opioid receptor antagonist being developed by Johnson & Johnson for psychiatric conditions including major depressive disorder with anhedonia and schizophrenia.