Pregabalin versus sertraline in generalized anxiety disorder. An open label study.

OBJECTIVE: Generalized Anxiety Disorder (GAD) is a chronic mental illness with a prevalence of 5-7% in the general population. t GAD is characterized by extreme persistent worry, mostly about minor problems, involving pathological fear with high occurrences of vegetative disturbance. GAD leads to functional impairment and a significantly reduced patient's quality of life. According to the guidelines of the World Federation of Societies of Biological Psychiatry (WFSBP), the first-line treatments for GAD are Serotonin selective reuptake inhibitors (SSRIs), Selective serotonin- and norepinephrine reuptake inhibitors (SNRIs) and pregabalin, an atypical anxiolytic. In this study, both efficacy and tolerability of pregabalin were evaluated and compared with efficacy and tolerability of sertraline, an SSRI antidepressant. PATIENTS AND METHODS: 107 patients both male and female, aged 20-60 were included in the study. All patients were hospitalized outward at the Psychiatric Clinic. Patients fulfilled criteria for GAD, according to ICD-X and DSM-IV. Each patient was randomly assigned to 4 weeks of treatment with pregabalin (n=47) or sertraline (n=60). Patients treated with sertraline were previously treated with SSRIs and SNRIs without remission, according to the latest National Clinical Guideline issued by the National Institute of Health and Clinical Excellence for treating GAD (NICE). The primary analysis was the change in the Hamilton Rating Scale for Anxiety (HAMA), a total score from baseline to endpoint. The second indicator of efficacy was the change in the HAMA psychic (emotional) and somatic (physical) scores, weekly, till endpoint. Global clinical assessment was conducted by using the Clinical Global Impression change rating (CGI). RESULTS: Both pregabalin and sertraline showed good results in treating symptoms of Generalized Anxious Disorder. The onset of action was shorter in treatment with pregabalin compared to the treatment with sertraline. In the patients treated with sertraline, the anxiolytic effect was detectable after at least 14 days while pregabalin showed initial good results during the first week of treatment. Adverse effects were reported in 28% patients treated with pregabalin and 27% of patients treated with sertraline, without significant differences. There were no drop-out patients in neither group. Beside pharmacotherapy, each patient received 8 weeks of cognitive/behavior therapy. In concomitant therapy benzodiazepine was used (klonazepam, in low doses). In all patients adverse events were short-lasting withmild intensity and there were no withdrawal events during this study. CONCLUSIONS: Efficacy and tolerability of pregabalin were high. Compared to sertraline, pregabalin showed more rapid onset of action and equal efficacy. Adverse reactions are short-lasting and the dose depends. Our investigation showed that pregabalin, an atypic anxiolytic is efficient and well tolerable in treatment of GAD.