Role of Amisulpride Augmentation in Treatment Resistant Major Depressive Disorder: An Open Label Study from North India

Background: About 60% patients with major depressive disorder do not achieve a sufficient response to standard antidepressant therapy and about two-thirds of patients receiving initial antidepressant medication do not achieve remission. Various strategies are being employed to counter this problem. Studies have shown that atypical antipsychotics, augmented to antidepressants for major depressive disorder patients, produced higher response and remission rates. The data regarding the augmentation of antidepressants with amisulpride is very scarce as compared to other atypical antipsychotics. Objective: To evaluate whether augmentation with amisulpride is effective and tolerable in patients of major depressive disorder (MDD) who did not respond significantly to adequate trials of standard antidepressants. Methodology and Results: In our open label 6 weeks study, amisulpride was added to baseline antidepressant medication of treatment resistant patients of major depressive disorder. A total of 112 patients enrolled in the study with a mean age of 39.37 years out of which 83% completed the study. Over a period of 6 weeks, 71% patient showed response and 40% patient remitted (p<0.001) with a mean amisulpride dose of 135.31 mg/day. The mean decrease in HAM-D17 score was 16.17 points. There was more than 2 point change in mean CGI-S score from base line to endpoint. Common adverse effects were akathisia (4.64%), sleep disturbances (10.71%), restlessness (5.36%) and extrapyramydial side-effects (4.64%). Conclusion: Augmentation of antidepressant drugs with low doses of amisulpride seems to be effective and tolerable in patients of major depressive disorder who do not respond adequately to standard antidepressant medications.