Abstract

AN OPEN-LABEL, RANDOMIZED, PARALLEL-GROUP, PROSPECTIVE CLINICAL TRIAL FOR EVALUATION OF EFFICACY AND SAFETY OF AGOMELATINE IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER

Author(s): Manish N. Thakre 1 , Anand M. Saoji 2 , Sudhir L. Mahajan 3

Agomelatine is one of the newer antidepressant drugs with potent melatonergic properties which tend to resynchronize the circadian rhythm. This study attempts to compare the efficacy of Agomelatine with Fluoxetine in patients with Major Depressive Disorder. METHODS This is a prospective, interventional, open-label, randomized, comparative, parallel-group study conducted at a private psychiatry clinic in Central India as a part of multi-centre clinical trial. A total of 23 patients with Major Depressive Disorder (having a total score of >20 in HDRS-17 scale and a score of at least 4 in CGI-S) were screened at our site and out of them 21 patients were randomized to either Agomelatine or fluoxetine (11 on Agomelatine and 10 on fluoxetine treatment). These patients were followed up prospectively on Day 15th, Day 29th, Day 43rd and Day 57th after randomization and HDRS 17 scale along with CGIS scale were applied at these visits. Tolerability to the study drugs were assessed by evaluation of adverse events reported voluntarily, observed on physical and systemic examination, or found on laboratory investigations during the study period. RESULTS It was found that patients from both the treatment groups (Agomelatine and Fluoxetine) showed statistically significant (p<0.001) improvement in major depression symptoms in terms of reduction in HDRS-17 score and CGI-S score. Also, in terms of safety, there was no reported serious adverse event with Agomelatine. CONCLUSION Agomelatine can be an important effective therapeutic option in the treatment of major depressive disorder. However, considering the small sample size from this center, it is suggested that the data/results presented in this report should be read in conjunction with the data from other centers.