Objective: Psychiatric disorders, particularly psychosis, depression, personality and behavioral disorders, mental retardation and anxiety disorders, are frequent comorbidities in patients with epilepsy. According to our own recent data, 19.6% of patients with refractory focal epilepsy also have a diagnosis of anxiety disorder. The purpose of the study reported here was to evaluate the efficacy and safety of pregabalin (PGB) in patients with comorbid epilepsy and anxiety disorder. Methods: In an open, uncontrolled study, 45 patients with intractable partial-onset epilepsy were treated with pregabalin at daily doses up to 600mg for 12weeks (including titration) in addition to their existing medication. Two groups of patients were examined: a group with an additional anxiety disorder and one without this comorbidity. In addition to changes in seizure characteristics, changes of psychological parameters were assessed. We used a disorder-specific questionnaire battery in panic disorder and agoraphobia with sub-questionnaires concerning body-related fears (BSQ), cognitions (ACQ), avoidance (MI), the Beck Depression Inventory (BDI), the questionnaire on life satisfaction (FLZ), PESOS, the Symptom Checklist (SCL-90-R), the Social Interaction Anxiety Scale (SIAS), the Social Phobias Scale (SPS) and the State-Trait Anxiety Inventory (STAI). Results: Data are available for 33 patients. Patients with epilepsy and comorbid anxiety disorder (n=12) showed significant improvements in the anxiety and social sensitivity subscales of the SCL-90-R and a positive trend in the phobia subscale. In addition, there was an improvement in the “Trait” subscale of the STAI. Conclusions: Our results indicate favorable effects of PGB on a comorbid anxiety disorder in patients with focal intractable epilepsy. Verification of the data obtained in this study in a large, randomized survey is desirable and necessary. The development and testing of psychotherapeutic methods that are tailored to the comorbidity of epilepsy and anxiety disorder should be discussed. Supported by: Pfizer.