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Background: Anxiety and irritability often coexist in patients with major depressive disorder (MDD). The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) added criteria for an anxious distress specifier for MDD. This study aimed at understanding the various components of anxiety and irritability, their impact, and relationships among them in MDD; and the association of anxious distress and irritability with treatment response. Methods: Focus groups were conducted with patients with MDD reporting symptoms of anxiety, irritability, agitation, and/or aggression. Clinical study data were pooled from open-label antidepressant treatment (ADT) phases of seven studies in patients with MDD and a history of inadequate response for the current depressive episode to one to three ADTs (N = 5,182). Post hoc criteria using study measures were applied to identify patients with symptoms of anxious distress and irritability. ADT response rates were compared for patients with and without anxious distress and irritability. Results: Symptoms of anxiety and irritability frequently coexisted for the focus group participants who often described symptoms of anxious distress (e.g., nervous, tense, restless, worry, fear, out of control, acting out). In the clinical studies, approximately 50% of patients with inadequate response to ADTs presented with symptoms of anxious distress and irritability. The presence of anxious distress was associated with lower ADT response rates. Conclusions: Various anxiety symptoms, including those comprising anxious distress, are prevalent and meaningful in depression, and frequently associated with irritability. Symptoms of anxious distress are associated with a decreased likelihood of ADT response.

Objective: Obtaining patient and caregiver perspectives may be critical for informing disease management, particularly with conditions like schizophrenia. The primary objective of the current study was to obtain and assess patient and caregiver perspectives on associated symptoms and behaviors of schizophrenia and their impact or burden on patients and their caregivers through patient interviews and caregiver focus groups. Research design and methods: Seven in-depth individual interviews were conducted with individuals with schizophrenia, and four focus groups were conducted with caregivers of adults with schizophrenia (n = 21) in two different locations in the United States. Following a discussion guide, interviewers asked open-ended questions to ascertain specific definitions and experiences related to five associated symptoms and behaviors (anxiety, irritability, agitation, impulsivity, and aggression), the impact of these symptoms, and how they were associated with schizophrenia. Additionally, patients completed the 8-item Birchwood Insight Scale developed to assess insight in patients with schizophrenia. Results: The impacts of anxiety were the most widespread and persistent for the patients, primarily relating to social and family interactions and relationships. For both patients and caregivers, patients’ anxiety comprised a mental and a physical component and contributed to escalation of other emotions and behaviors. Other significant or debilitating impacts, such as emotional functioning, legal issues, and financial distress, were attributed to aggression and impulsivity for both the patients and the caregivers. Conclusion: This study provides evidence of the impact of anxiety in the lives of patients with schizophrenia and their caregivers, and the potential relationship of and escalation from anxiety to aggression. Additionally, the study reinforces the importance of ensuring that treatment is taking into account the highly prevalent anxiety symptoms and behavioral disturbances in patients with schizophrenia as well as the implications of these symptoms and disturbances on the caregivers.