Evaluation of efficacy and safety of sertraline in the treatment of major depressive disorders

ABSTRACT

An open, non-comparative study was carried out on 30 patients [21 females and 9 males], their ages ranged from 18 to 60 years, their weights between 50 to 86 kgs. They were randomly selected from the psychiatric out-patient clinic at Manial University Hospital, Cairo University, Cairo. The period of active treatment with sertraline continued for six weeks. The drug was administered in increasing doses from 50mg/day to a maximum of 200mg/day, according to the clinical response and the safety. Baseline assessment and assessment during therapy was carried out. Laboratory tests, Hamilton Rating Scale [HAM-D and HAM-A] and Clinical Global Impression Scale were done on six visits. All patients included in the study were suffering from major depressive disorder [DSM-III R] suitable for antidepressant therapy. Four cases discontinued treatment prematurely [3 males and one female], because of adverse side effects, and another female patient discontinued treatment after noticeable improvement in the first 3 weeks of the study. Results were statistically analysed using the paired-t-test and the Wilcoxon signed rank test. Adverse side effects were mainly in the autonomic nervous system especially related to the gastrointestinal tract. Thus, sertraline is a well-tolerated antidepressant, and the results of this study support its efficacy and safety in the treatment of patients with major depression