Purpose: This study was conducted among Japanese patients with generalized anxiety disorder (GAD) who had participated in a clinical trial to investigate their level of disease awareness, past medical care-seeking behavior and diagnoses, symptoms and impact on daily life, perceptions of diagnosis and clinical assessment, and changes after trial participation. The patients’ first-hand experiences related to symptoms and disease burden were collected through open-ended responses. Patients and Methods: This was a quantitative (descriptive observational) study using a web-based questionnaire conducted from April 23 to May 25, 2025. Patients diagnosed with GAD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, and previously enrolled in Study B2411367, a clinical trial of venlafaxine, a serotonin-norepinephrine reuptake inhibitor, were eligible. Results: Data from 98 respondents were analyzed. The most frequently reported GAD symptoms at trial entry included excessive anxiety or worry (99.0%), becoming fatigued easily (86.7%), and sleep problems (82.7%). Over half of respondents (53.1%) identified work or studying as the most affected area of daily life, describing impaired concentration, reduced efficiency, and physical strain. Regarding disease awareness, 72.4% of respondents had never heard of GAD and 71.4% attributed their anxiety to their personality. Only 11.2% had sought medical care before trial participation, with depression being the most frequent diagnosis (36.4%) and only 9.1% having been diagnosed with GAD. Conclusion: Many patients with GAD were unaware of the disease name before trial entry and had symptoms that impacted daily life. The patients’ first-hand accounts provided deeper insight into their burden. The findings highlight the unmet needs among Japanese patients with GAD who participated in a clinical trial and the situation of low public disease awareness and limited recognition in clinical settings. Efforts to increase awareness of GAD may help facilitate earlier diagnosis and broaden access to appropriate treatment. Clinical Trial Registration: UMIN000057689. Keywords: generalized anxiety disorder, awareness, Japan, questionnaire, patient, burden
Nomoto et al. (2026) studied this question.