Abstract: The disclosure provides compositions containing pure aticaprant, solvates of aticaprant, and methods of treating major depressive disorder using aticaprant.

Abstract: The invention provides methods of identifying schizophrenia patients at risk for relapse. The invention also provides methods of early detection of schizophrenic relapse. The disclosed methods use monitoring of a subset of symptoms and/or one or more biomarkers. The symptom severity can be assessed using the Positive and Negative Syndrome Scale (PANSS) parameters. The methods of the invention can be used to provide early intervention to decrease or prevent relapse in schizophrenia patients.

Abstract: The disclosure provides crystalline and amorphous forms of aticaprant. Also provided by the disclosure are pharmaceutical compositions comprising the amorphous or crystalline forms, methods of treating major depressive disorder using the amorphous or crystalline forms of aticaprant, amorphous or crystalline forms of aticaprant for use in the treatment of major depressive disorder in a human patient having anhedonia, uses of the amorphous or crystalline forms of aticaprant in the manufacture of a medicament for the treatment of major depressive disorder, and packages or pharmaceutical products comprising (i) amorphous or crystalline forms of aticaprant and (ii) instructions for treating major depressive disorder. In some aspects, the human patient treated as described herein has anhedonia.

Abstract: The present disclosure relates to compositions, including oral compositions in the form of tablets, comprising aticaprant and methods of using the same.

Abstract: The invention provides methods of identifying schizophrenia patients at risk for relapse. The invention also provides methods of early detection of schizophrenic relapse. The disclosed methods use monitoring of a subset of symptoms and/or one or more biomarkers. The symptom severity can be assessed using the Positive and Negative Syndrome Scale (PANSS) parameters. The methods of the invention can be used to provide early intervention to decrease or prevent relapse in schizophrenia patients.

Abstract: The disclosure provides methods for treating major depressive disorder in a human patient having moderate or severe anhedonia. The methods comprise administering to the patient in need thereof an effective amount of aticaprant, or a pharmaceutically acceptable salt thereof. In some embodiments, the patient had an inadequate response to other antidepressant therapy prior to treatment with aticaprant. In other embodiments, the other antidepressant therapy comprised a selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI), or a combination thereof.

Abstract: This invention relates to the use of (4-benzylpiperazin-1-yl)-[2-(3-methylbutylamino)pyridin-3-yl]methanone (NSI-189) or a pharmaceutically acceptable salt thereof in the treatment of a psychiatric condition in which depressive symptoms are prominent, including major depressive disorder, bipolar disorder, posttraumatic stress disorder, substance use disorder, and depression-related aspects of schizophrenia (e.g. negative symptoms), in a patient who is cognitively impaired or has poor or slow cognition or difficulty making decisions or exhibits certain EEG properties. The present invention also relates to the selection of patients with a biomarker (e.g., EEG) and/or clinical symptoms who would most benefit from such compounds.

Abstract: The disclosure provides methods for treating major depressive disorder in a human patient having moderate or severe anhedonia. The methods comprise administering to the patient in need thereof an effective amount of aticaprant, or a pharmaceutically acceptable salt thereof. In some embodiments, the patient had an inadequate response to other antidepressant therapy prior to treatment with aticaprant. In other embodiments, the other antidepressant therapy comprised a selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI), or a combination thereof.

Abstract: The disclosure provides methods for treating major depressive disorder in a human patient having moderate or severe anhedonia. The methods comprise administering to the patient in need thereof an effective amount of aticaprant, or a pharmaceutically acceptable salt thereof. In some embodiments, the patient had an inadequate response to other antidepressant therapy prior to treatment with aticaprant. In other embodiments, the other antidepressant therapy comprised a selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI), or a combination thereof.

Abstract: The invention provides methods of identifying schizophrenia patients at risk for relapse. The invention also provides methods of early detection of schizophrenic relapse. The disclosed methods use monitoring of a subset of symptoms and/or one or more biomarkers. The symptom severity can be assessed using the Positive and Negative Syndrome Scale (PANSS) parameters. The methods of the invention can be used to provide early intervention to decrease or prevent relapse in schizophrenia patients.