A Comparative Study of Efficacy and Safety of Agomelatine and Escitalopram in Major Depressive Disorder.
BACKGROUND
Major depressive disorder (MDD) is a mental disorder characterized by episodes of depressed mood, loss of interest or pleasure, feeling of guilt or low self-esteem, loss of energy, altered sleep patterns and difficulty in concentration.


OBJECTIVE
This study was carried out to compare the efficacy and safety of Agomelatine with Escitalopram in the treatment of major depressive disorder.


METHODS
This is a prospective study conducted at Outpatient Department of Psychiatry, GSL Medical College & General hospital, Rajahmundry, India.


METHODS
Patients with newly diagnosed major depressive disorder (DSM-IV-TR) with minimum score of 20 in Hamilton depression rating scale were randomly assigned Agomelatine (25-50 mg/day) or Escitalopram (10-20 mg/day) for a period of 8 weeks. The main efficacy outcome considered was the mean change of HAM-D17 score from baseline to end of therapy. Secondary outcome measures were Clinical Global Impressions-improvement (CGI) and severity (CGI-S) rating scales.


METHODS
Student t-test was used for comparing the groups and chi-square test was used for assessing the qualitative variables. For all statistical analysis p<0.05 was considered statistically significant.


RESULTS
The drugs under study effectively reduced depressive symptoms at all the time points. The percentage of responders at 8weeks (last post baseline value) was 65.38% with Agomelatine and 57.40% with Escitalopram. The difference between the drugs was statistically not significant in all evaluations (p>0.05). The mean CGI-S and CGI-I scores were decreased in both the groups (p<0.05) and there was no statistically significant difference between the groups at any assessment during the study period. Both the treatment groups showed favourable safety profile.


CONCLUSIONS
The study results supported that Agomelatine is therapeutically similar to Escitalopram in terms of antidepressant effect.
Associate Professor, Department of Pharmacology, GSL Medical college & General Hospital , Rajahmundry, Andhra Pradesh, India .
Ravi Babu
RB
Komaram
Associate Professor, Department of Psychiatry, GSL Medical college & General Hospital , Rajahmundry, Andhra Pradesh, India .
Srikrishna
S
Nukala
Postgraduate Student, Department of Community Medicine, GSL Medical college & General Hospital , Rajahmundry, Andhra Pradesh, India .
Jayasree
J
Palla
Assistant Professor in statistics, Department of Community Medicine, RIMS , Ongole, Andhra Pradesh, India .
Lakshmana Rao
LR
Nambaru
Professor & HOD, Department of Pharmacology, GSL Medical college & General Hospital , Rajahmundry, Andhra Pradesh, India .
Satyanarayana Murthy
SM
Kasturi
5-HT2C receptors; Antidepressants; Depression; Melatonergic receptors